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Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)

Sponsor
Baxter Healthcare Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT02860130
Collaborator
(none)
34
Enrollment
12
Locations
2
Arms
19.4
Actual Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.

Condition or Disease Intervention/Treatment Phase
  • Drug: Prismocitrate 18
  • Other: No Anticoagulation
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
Actual Study Start Date :
Sep 27, 2016
Actual Primary Completion Date :
May 12, 2018
Actual Study Completion Date :
May 12, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prismocitrate 18

Drug: Prismocitrate 18
Modality of CVVHDF
Other Names:
  • Regional Citrate Anticoagulation (RCA)

    		•
    Active Comparator: No Regional Anticoagulation of CRRT Circuit

    Other: No Anticoagulation
    Modality of CVVHDF

    Outcome Measures

    Primary Outcome Measures

    1. Time to Occurrence of Selected Prismaflex® System Alarms/Conditions [Up to 120 hours post CRRT treatment initiation]

      The point estimate is time point (number of hours of the extracorporeal circuit life of a filter) at which (100-percentile)% filters are still surviving (i.e. number surviving divided by number at risk), based on the Kaplan-Meier method. For example, for the 25th percentile: after 33.18 hours, 75% of filters are still surviving. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints. The Prismaflex M150 Set extracorporeal circuit life of filters were intended to be assessed over a maximum of 120 hours (Treatment Period) by duration of time for which each Prismaflex M150 Set could be used continuously over a maximum 72 hour time-period in each patient. The end of the extracorporeal circuit life was defined by the occurrence of one or both of the following Prismaflex® System alarms/conditions if the alarms could not be mitigated: (1) "Warning: Filter Clotted", and/or (2) "Advisory transmembrane pressure (TMP) Too High."

    Secondary Outcome Measures

    1. Change From Baseline in Patient Ionized Calcium (iCa) by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

      Systemic blood iCa concentrations

    2. Extracorporeal Circuit Ionized Calcium by Hour [Up to 120 hours post CRRT treatment initiation]

      Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm. The extracorporeal circuit (post-filter).

    3. Delivery of Prescribed CRRT Dose by Day [Up to 120 hours post CRRT treatment initiation]

      Evaluates the efficacy of using Prismocitrate 18 in delivering the prescribed CRRT dose, with delivered dose based on (daily) average effluent rate divided by (daily) average weight and expressed as mL/kg/hour.

    4. Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment [Prior to study use of Prismocitrate 18]

      Training conducted on administration of Prismocitrate 18 to demonstrate the understanding of the user groups on how to use the solution by passing an assessment at the end of training. The user groups who needed to be assessed prior to use of Prismocitrate 18 in the clinical trial setting were to be comprised of physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment during the 120 hour Treatment Period. The training assessment was housed on a restricted access study website. Study personnel who completed the training assessment have a completion date listed which indicates that the individual received a passing score of 80% or better on the training assessment.

    5. Change From Baseline in Serum Bicarbonate by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    6. Change From Baseline in pH by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    7. Change From Baseline in Base Excess by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    8. Change From Baseline in Blood Total Calcium Concentration by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    9. Change From Baseline in Serum Sodium by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    10. Change From Baseline in Serum Anion Gap by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    11. Change From Baseline in Serum Magnesium by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    12. Change From Baseline in Serum Phosphate by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    13. Change From Baseline in Serum Potassium by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    14. Change From Baseline in Serum Chloride by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    15. Number of Participants With Bleeding Events [Up to 120 hours post CRRT treatment initiation]

    16. Number of Participants by Number of Blood Transfusions [Up to 120 hours post CRRT treatment initiation]

    17. Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious) [Up to 30 days post study CRRT treatment completion]

    18. Change From Baseline in Blood Pressure at Last Visit [Baseline and up to 120 hours post CRRT treatment initiation]

    19. Change From Baseline in Respiratory Rate at Last Visit [Baseline and up to 120 hours post CRRT treatment initiation]

    20. Change From Baseline in Temperature at Last Visit [Baseline and up to 120 hours post CRRT treatment initiation]

    21. Change From Baseline in Pulse at Last Visit [Baseline and up to 120 hours post CRRT treatment initiation]

    22. Change From Baseline in Total Calcium/iCa Ratio by Hour [Baseline and up to 120 hours post CRRT treatment initiation]

    23. Number of Bleeding Events by Location [Up to 120 hours post CRRT treatment initiation]

    24. Duration of Bleeding Events [Up to 120 hours post CRRT treatment initiation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patient must be receiving medical care in an intensive care unit (ICU) (e.g., medical ICU, surgical ICU, cardiothoracic ICU, Trauma ICU, Mixed ICU, other).

    2. Adult patients with AKI or other serious conditions who require treatment with CRRT.

    3. Patients are expected to remain in the ICU and on CRRT for at least 72 hours after randomization.

    4. Patients already receiving standard-of-care CRRT must be randomized within 24 hours of initiation of their standard-of-care CRRT.

    Exclusion Criteria:

    1. Patients requiring systemic anticoagulation with antithrombotic agents for reasons other than CRRT. The exception is patients receiving subcutaneous heparin for deep vein thrombosis prophylaxis according to institutional practice or patients on aspirin may be enrolled.

    2. Patients in whom citrate anticoagulation is contraindicated such as patients with a known allergy to citrate or who have experienced adverse events associated with citrate products including patients with a prior history of citrate toxicity or patients with uncorrected severe hypocalcemia (whether in the context of current citrate administration or due to the underlying disease state).

    3. Patients who are not candidates for CRRT.

    4. Patients who are receiving extracorporeal membrane oxygenation (ECMO) therapy.

    5. Patients with severe coagulopathy [i.e., platelets < 30,000/mm3, international normalized ratio (INR) > 2, partial thromboplastin time (PTT) > 50 seconds] including severe thrombocytopenia (platelets < 30,000/mm3), HIT (heparin induced thrombocytopenia), ITP (idiopathic thrombocytopenia purpura), and TTP (thrombotic thrombocytopenia purpura) should not be enrolled in the trial.

    6. Patients with fulminant acute liver failure or acute on chronic liver failure as documented by a Child-Pugh Liver Failure Score > 10.

    7. Patients with refractory shock associated persistent, worsening with lactic acidosis (lactate > 4 mmol/L). However, patients with improving subsequent serum lactate levels may be enrolled.

    8. Patients unlikely to survive at least 72 hours.

    9. Female patients who are pregnant, lactating, or planning to become pregnant during the study period.

    10. Patients who are currently participating in another interventional clinical study.

    11. Patients with a medical condition that may interfere with the study objectives.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 University of Arizona Tucson Arizona United States 85724
    3 Yale University School of Medicine New Haven Connecticut United States 06520
    4 Emory University Atlanta Georgia United States 30322
    5 Northwestern University Chicago Illinois United States 60611
    6 University of Kansas Medical Center Kansas City Kansas United States 66160
    7 University of Kentucky Lexington Kentucky United States 40526
    8 University of Maryland Medical Center Baltimore Maryland United States 21201
    9 Beth Israel Deaconess (Harvard) Boston Massachusetts United States 02215
    10 University of Mississippi Medical Center Jackson Mississippi United States 39216
    11 Cleveland Clinic Cleveland Ohio United States 44195
    12 University of Alberta Hospital Edmonton Alberta Canada T6G2B7

    Sponsors and Collaborators

    • Baxter Healthcare Corporation

    Investigators

    • Study Director: Qing Li, MD, Baxter Healthcare Corporation

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Baxter Healthcare Corporation
    ClinicalTrials.gov Identifier:
    NCT02860130
    Other Study ID Numbers:
    • 1407-004
    First Posted:
    Aug 9, 2016
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Baxter Healthcare Corporation
    Regional Citrate Anticoagulation (RCA)
    Continuous Renal Replacement Therapy (CRRT)
    Acute Kidney Injury
    Additional relevant MeSH terms:
    Acute Kidney Injury

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Period Title: Overall Study
    STARTED 17 17
    COMPLETED 10 8
    NOT COMPLETED 7 9

    Baseline Characteristics

    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation Total
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). Total of all reporting groups
    Overall Participants 17 17 34
    Age, Customized (Count of Participants)
    ≥ 18 years to ≤ 35 years
    1
    5.9%
    0
    0%
    1
    2.9%
    > 35 years to ≤ 45 years
    2
    11.8%
    1
    5.9%
    3
    8.8%
    > 45 years to ≤ 55 years
    1
    5.9%
    3
    17.6%
    4
    11.8%
    > 55 years to ≤ 65 years
    4
    23.5%
    4
    23.5%
    8
    23.5%
    > 65 years
    9
    52.9%
    9
    52.9%
    18
    52.9%
    Sex: Female, Male (Count of Participants)
    Female
    6
    35.3%
    10
    58.8%
    16
    47.1%
    Male
    11
    64.7%
    7
    41.2%
    18
    52.9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    11.8%
    8
    47.1%
    10
    29.4%
    White
    15
    88.2%
    9
    52.9%
    24
    70.6%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    17
    100%
    17
    100%
    34
    100%

    Outcome Measures

    1. Primary Outcome
    Title Time to Occurrence of Selected Prismaflex® System Alarms/Conditions
    Description The point estimate is time point (number of hours of the extracorporeal circuit life of a filter) at which (100-percentile)% filters are still surviving (i.e. number surviving divided by number at risk), based on the Kaplan-Meier method. For example, for the 25th percentile: after 33.18 hours, 75% of filters are still surviving. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints. The Prismaflex M150 Set extracorporeal circuit life of filters were intended to be assessed over a maximum of 120 hours (Treatment Period) by duration of time for which each Prismaflex M150 Set could be used continuously over a maximum 72 hour time-period in each patient. The end of the extracorporeal circuit life was defined by the occurrence of one or both of the following Prismaflex® System alarms/conditions if the alarms could not be mitigated: (1) "Warning: Filter Clotted", and/or (2) "Advisory transmembrane pressure (TMP) Too High."
    Time Frame Up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)-randomized treatment groups (intent-to-treat principle)
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    25 Percentile
    33.180
    17.680
    50 Percentile
    NA
    29.660
    75 Percentile
    NA
    NA
    2. Secondary Outcome
    Title Change From Baseline in Patient Ionized Calcium (iCa) by Hour
    Description Systemic blood iCa concentrations
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    1 Hour
    -0.1
    (0.14)
    0
    (0.06)
    6 Hours
    -0.1
    (0.11)
    0
    (0.07)
    12 Hours
    -0.0
    (0.17)
    0
    (0.1)
    18 Hours
    0
    (0.18)
    0
    (0.12)
    24 Hours
    0.1
    (0.19)
    -0.0
    (0.17)
    30 Hours
    0
    (0.17)
    0
    (0.13)
    36 Hours
    0
    (0.14)
    -0.0
    (0.12)
    42 Hours
    0
    (0.18)
    0
    (0.15)
    48 Hours
    0
    (0.15)
    0
    (0.16)
    54 hours
    0
    (0.14)
    -0.0
    (0.15)
    60 hours
    0
    (0.12)
    -0.0
    (0.15)
    66 Hours
    -0.0
    (0.14)
    -0.0
    (0.15)
    72 Hours
    0
    (0.13)
    0
    (0.16)
    78 Hours
    0
    (0.16)
    0
    (0.16)
    84 Hours
    0
    (0.15)
    -0.0
    (0.17)
    90 Hours
    0
    (0.17)
    -0.0
    (0.15)
    96 Hours
    0
    (0.11)
    -0.0
    (0.16)
    102 Hours
    0
    (0.14)
    0
    (0.16)
    108 Hours
    0
    (0.14)
    0
    (0.16)
    114 Hours
    0.1
    (0.13)
    0
    (0.15)
    120 Hours
    0.1
    (0.14)
    -0.0
    (0.15)
    3. Secondary Outcome
    Title Extracorporeal Circuit Ionized Calcium by Hour
    Description Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm. The extracorporeal circuit (post-filter).
    Time Frame Up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17
    1 Hour
    0.5
    (0.11)
    6 Hours
    0.5
    (0.13)
    12 Hours
    0.5
    (0.11)
    18 Hours
    0.5
    (0.11)
    24 Hours
    0.5
    (0.11)
    30 Hours
    0.5
    (0.11)
    36 Hours
    0.5
    (0.1)
    42 Hours
    0.5
    (0.23)
    48 Hours
    0.5
    (0.12)
    54 hours
    0.5
    (0.11)
    60 hours
    0.5
    (0.13)
    66 Hours
    0.5
    (0.17)
    72 Hours
    0.4
    (0.1)
    78 Hours
    0.4
    (0.12)
    84 Hours
    0.4
    (0.11)
    90 Hours
    0.4
    (0.1)
    96 Hours
    0.4
    (0.11)
    102 Hours
    0.4
    (0.13)
    108 Hours
    0.4
    (0.11)
    114 Hours
    0.4
    (0.11)
    120 Hours
    0.5
    (0.16)
    4. Secondary Outcome
    Title Delivery of Prescribed CRRT Dose by Day
    Description Evaluates the efficacy of using Prismocitrate 18 in delivering the prescribed CRRT dose, with delivered dose based on (daily) average effluent rate divided by (daily) average weight and expressed as mL/kg/hour.
    Time Frame Up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    Day 1
    32.3
    (7.064)
    30.34
    (7.407)
    Day 2
    33.12
    (9.676)
    32.49
    (10.191)
    Day 3
    31.62
    (8.045)
    32.29
    (10.533)
    Day 4
    31.93
    (10.187)
    35.19
    (10.95)
    Day 5
    32.83
    (11.119)
    33.31
    (13.103)
    5. Secondary Outcome
    Title Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment
    Description Training conducted on administration of Prismocitrate 18 to demonstrate the understanding of the user groups on how to use the solution by passing an assessment at the end of training. The user groups who needed to be assessed prior to use of Prismocitrate 18 in the clinical trial setting were to be comprised of physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment during the 120 hour Treatment Period. The training assessment was housed on a restricted access study website. Study personnel who completed the training assessment have a completion date listed which indicates that the individual received a passing score of 80% or better on the training assessment.
    Time Frame Prior to study use of Prismocitrate 18

    Outcome Measure Data

    Analysis Population Description
    Physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment at each Investigator site. Staff at each site facility passed testing, but the overall number of participants is not known. No analysis of investigator training test scores were conducted as results for individual test questions were not retained for analysis.
    Arm/Group Title Prismocitrate 18
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants NA
    Measure site facilities 6
    Number [site facility staff]
    6
    6. Secondary Outcome
    Title Change From Baseline in Serum Bicarbonate by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    6 Hours
    0.2
    (3.86)
    2.4
    (3.48)
    12 Hours
    0.8
    (4.42)
    2.9
    (3.27)
    18 Hours
    1.3
    (5.43)
    2.3
    (4.11)
    24 Hours
    2.8
    (4.64)
    2
    (4.99)
    30 Hours
    2.9
    (5.02)
    2.9
    (4.21)
    36 Hours
    3.3
    (5.6)
    2.6
    (3.71)
    42 Hours
    3.3
    (5.52)
    3.6
    (3.61)
    48 Hours
    2.7
    (5.56)
    2.4
    (3.99)
    54 Hours
    2.7
    (5.72)
    2.1
    (3.77)
    60 Hours
    4.7
    (6.56)
    2.4
    (4.29)
    66 Hours
    3.7
    (6.49)
    2.6
    (5.02)
    72 Hours
    4.2
    (6.59)
    0.1
    (6.68)
    78 Hours
    2.8
    (5.01)
    2.9
    (5.46)
    84 Hours
    3.3
    (5.48)
    2.5
    (5.34)
    90 Hours
    3.3
    (6.05)
    2.2
    (5.26)
    96 Hours
    2.8
    (5.88)
    1.4
    (5.81)
    102 Hours
    2.2
    (5.64)
    -1.1
    (7.48)
    108 Hours
    2.7
    (5.25)
    -0.4
    (7.67)
    114 Hours
    3.8
    (6.2)
    -2.8
    (8)
    120 Hours
    2.8
    (5.94)
    -1.5
    (7.13)
    7. Secondary Outcome
    Title Change From Baseline in pH by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    6 Hours
    -0.0
    (0.06)
    0.1
    (0.09)
    12 Hours
    -0.0
    (0.07)
    0.1
    (0.1)
    18 Hours
    0
    (0.1)
    0
    (0.11)
    24 Hours
    0
    (0.1)
    0
    (0.1)
    30 Hours
    0
    (0.1)
    0.1
    (0.11)
    36 Hours
    0
    (0.11)
    0.1
    (0.1)
    42 Hours
    0
    (0.11)
    0.1
    (0.09)
    48 Hours
    0
    (0.12)
    0.1
    (0.1)
    54 Hours
    0
    (0.13)
    0.1
    (0.09)
    60 Hours
    0
    (0.14)
    0.1
    (0.08)
    66 Hours
    0.1
    (0.16)
    0
    (0.07)
    72 Hours
    0
    (0.13)
    0
    (0.16)
    78 Hours
    0
    (0.13)
    0.1
    (0.11)
    84 Hours
    0.1
    (0.12)
    0.1
    (0.09)
    90 Hours
    0
    (0.14)
    0.1
    (0.1)
    96 Hours
    0
    (0.16)
    0.1
    (0.14)
    102 Hours
    0
    (0.12)
    0
    (0.11)
    108 Hours
    0
    (0.11)
    0.1
    (0.16)
    114 Hours
    0
    (0.12)
    -0.0
    (0.12)
    120 Hours
    -0.0
    (0.12)
    0
    (0.17)
    8. Secondary Outcome
    Title Change From Baseline in Base Excess by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    6 Hours
    0.4
    (6.92)
    1.1
    (4.72)
    12 Hours
    -1.3
    (5.06)
    1.7
    (4.75)
    18 Hours
    0.3
    (7.28)
    1.1
    (6.08)
    24 Hours
    2.4
    (6.65)
    0.6
    (6.15)
    30 Hours
    1.3
    (5.64)
    1.7
    (5.91)
    36 Hours
    3
    (7.36)
    0.9
    (5.74)
    42 Hours
    2.8
    (7.41)
    2.1
    (6.09)
    48 Hours
    2.4
    (6.87)
    1.9
    (5.67)
    54 Hours
    1.3
    (6.99)
    0.4
    (5.78)
    60 Hours
    3.7
    (7.57)
    1.2
    (7.26)
    66 Hours
    3.2
    (8.43)
    2.1
    (5.2)
    72 Hours
    3.6
    (7.5)
    -2.1
    (12.94)
    78 Hours
    2.5
    (5.77)
    4
    (5.98)
    84 Hours
    4
    (6.61)
    3.7
    (5.27)
    90 Hours
    3
    (5.98)
    3.1
    (5.53)
    96 Hours
    3.5
    (7.29)
    2.2
    (5.91)
    102 Hours
    1.6
    (5.56)
    -1.0
    (9.04)
    108 Hours
    3.5
    (5.95)
    0.8
    (9.34)
    114 Hours
    2.7
    (5.72)
    -2.8
    (9.47)
    120 Hours
    2.8
    (7.23)
    -2.0
    (8.94)
    9. Secondary Outcome
    Title Change From Baseline in Blood Total Calcium Concentration by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    1 Hour
    -0.0
    (0.12)
    -0.0
    (0.13)
    6 Hours
    0.1
    (0.21)
    -0.0
    (0.14)
    12 Hours
    0.2
    (0.27)
    -0.0
    (0.19)
    18 Hours
    0.2
    (0.25)
    -0.0
    (0.22)
    24 Hours
    0.3
    (0.24)
    -0.1
    (0.31)
    30 Hours
    0.3
    (0.22)
    -0.0
    (0.22)
    36 Hours
    0.3
    (0.24)
    -0.1
    (0.24)
    42 Hours
    0.3
    (0.28)
    -0.1
    (0.22)
    48 Hours
    0.3
    (0.26)
    -0.1
    (0.27)
    54 Hours
    0.3
    (0.24)
    -0.1
    (0.25)
    60 Hours
    0.3
    (0.24)
    -0.1
    (0.24)
    66 Hours
    0.3
    (0.27)
    -0.1
    (0.26)
    72 Hours
    0.3
    (0.27)
    -0.1
    (0.26)
    78 Hours
    0.3
    (0.29)
    -0.1
    (0.24)
    84 Hours
    0.3
    (0.33)
    -0.2
    (0.27)
    90 Hours
    0.3
    (0.35)
    -0.1
    (0.27)
    96 Hours
    0.2
    (0.27)
    -0.2
    (0.27)
    102 Hours
    0.2
    (0.27)
    -0.1
    (0.29)
    108 Hours
    0.3
    (0.35)
    -0.1
    (0.29)
    114 Hours
    0.2
    (0.27)
    -0.2
    (0.25)
    120 Hours
    0.4
    (0.2)
    -0.1
    (0.24)
    10. Secondary Outcome
    Title Change From Baseline in Serum Sodium by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    6 Hours
    -1.1
    (2.89)
    0.4
    (1.89)
    12 Hours
    -1.6
    (2.06)
    -0.1
    (3.01)
    18 Hours
    -1.7
    (2.13)
    0.5
    (3.39)
    24 Hours
    -1.7
    (4.19)
    0.4
    (4.35)
    30 Hours
    -1.9
    (4.03)
    0.4
    (4.83)
    36 Hours
    -1.1
    (5.13)
    -0.3
    (5.08)
    42 Hours
    -0.7
    (5.15)
    -0.4
    (5.04)
    48 Hours
    -1.5
    (5.74)
    1.2
    (4.47)
    54 Hours
    -1.3
    (6.29)
    0.5
    (4.95)
    60 Hours
    -1.3
    (5.86)
    1
    (4.99)
    66 Hours
    -0.7
    (6.1)
    0.3
    (4.11)
    72 Hours
    -0.8
    (5.62)
    2.5
    (4.61)
    78 Hours
    -1.8
    (5.21)
    2.6
    (4.06)
    84 Hours
    -2.2
    (4.95)
    1.7
    (4.87)
    90 Hours
    -1.8
    (4.17)
    2.2
    (4.47)
    96 Hours
    -2.0
    (4.51)
    2.3
    (3.24)
    102 Hours
    -1.8
    (4.9)
    1.1
    (3.53)
    108 Hours
    -2.4
    (4.36)
    0.7
    (3.73)
    114 Hours
    -2.8
    (4.78)
    1.4
    (4.12)
    120 Hours
    -3.7
    (4.39)
    1
    (5.16)
    11. Secondary Outcome
    Title Change From Baseline in Serum Anion Gap by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    6 Hours
    0.6
    (3.08)
    -2.3
    (2.27)
    12 Hours
    0.6
    (2.45)
    -3.5
    (3.1)
    18 Hours
    0.2
    (2.96)
    -2.2
    (4.72)
    24 Hours
    -0.5
    (3.07)
    -2.9
    (3.24)
    30 Hours
    1.6
    (3.08)
    -3.6
    (3.55)
    36 Hours
    0.5
    (3.41)
    -4
    (2.73)
    42 Hours
    0.7
    (3.33)
    -3.5
    (2.9)
    48 Hours
    0.7
    (3.7)
    -2.8
    (3.21)
    54 Hours
    0.3
    (3.47)
    -3.2
    (3.27)
    60 Hours
    0.4
    (3.58)
    -2.3
    (3.67)
    66 Hours
    1.1
    (4)
    -3.2
    (4.37)
    72 Hours
    1
    (4.37)
    0
    (5.93)
    78 Hours
    0.7
    (2.39)
    -2.0
    (3.4)
    84 Hours
    0.8
    (2.74)
    -3.0
    (3.91)
    90 Hours
    0.8
    (3.59)
    -2.1
    (3.54)
    96 Hours
    1.6
    (2.35)
    -1.7
    (4.21)
    102 Hours
    1.5
    (2.54)
    -1.7
    (5.15)
    108 Hours
    0.8
    (2.67)
    0.6
    (5.44)
    114 Hours
    1
    (2.71)
    0.7
    (8.64)
    120 Hours
    -0.3
    (2.06)
    -1.2
    (7.03)
    12. Secondary Outcome
    Title Change From Baseline in Serum Magnesium by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    6 Hours
    -0.1
    (0.12)
    0
    (0.14)
    12 Hours
    -0.1
    (0.14)
    -0.0
    (0.14)
    18 Hours
    -0.1
    (0.19)
    0
    (0.14)
    24 Hours
    -0.2
    (0.2)
    -0.0
    (0.16)
    30 Hours
    -0.1
    (0.23)
    0
    (0.17)
    36 Hours
    -0.1
    (0.22)
    0
    (0.19)
    42 Hours
    -0.2
    (0.23)
    0
    (0.2)
    48 Hours
    -0.2
    (0.25)
    0.1
    (0.16)
    54 Hours
    -0.2
    (0.21)
    0
    (0.2)
    60 Hours
    -0.1
    (0.23)
    0
    (0.2)
    66 Hours
    -0.1
    (0.24)
    0
    (0.18)
    72 Hours
    -0.1
    (0.22)
    0.1
    (0.2)
    78 Hours
    -0.2
    (0.21)
    0.1
    (0.16)
    84 Hours
    -0.2
    (0.22)
    0
    (0.18)
    90 Hours
    -0.2
    (0.27)
    0.1
    (0.21)
    96 Hours
    -0.2
    (0.24)
    0.1
    (0.18)
    102 Hours
    -0.2
    (0.23)
    0.1
    (0.2)
    108 Hours
    -0.2
    (0.28)
    0.1
    (0.2)
    114 Hours
    -0.1
    (0.27)
    0.1
    (0.23)
    120 Hours
    -0.2
    (0.28)
    0
    (0.21)
    13. Secondary Outcome
    Title Change From Baseline in Serum Phosphate by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    6 Hours
    -0.3
    (0.33)
    -0.4
    (0.29)
    12 Hours
    -0.3
    (0.51)
    -0.4
    (0.32)
    18 Hours
    -0.5
    (0.7)
    -0.4
    (0.41)
    24 Hours
    -0.7
    (0.74)
    -0.4
    (0.36)
    30 Hours
    -0.6
    (0.7)
    -0.5
    (0.35)
    36 Hours
    -0.7
    (0.78)
    -0.4
    (0.32)
    42 Hours
    -0.8
    (0.82)
    -0.5
    (0.32)
    48 Hours
    -0.9
    (0.87)
    -0.4
    (0.33)
    54 Hours
    -0.8
    (0.86)
    -0.4
    (0.43)
    60 Hours
    -0.9
    (0.93)
    -0.4
    (0.41)
    66 Hours
    -0.8
    (0.89)
    -0.4
    (0.52)
    72 Hours
    -0.8
    (0.88)
    -0.2
    (0.74)
    78 Hours
    -0.8
    (0.86)
    -0.4
    (0.55)
    84 Hours
    -0.8
    (0.84)
    -0.4
    (0.48)
    90 Hours
    -0.8
    (0.84)
    -0.3
    (0.71)
    96 Hours
    -0.8
    (0.92)
    -0.5
    (0.6)
    102 Hours
    -0.7
    (0.85)
    -0.4
    (0.63)
    108 Hours
    -0.8
    (0.84)
    -0.4
    (0.76)
    114 Hours
    -0.9
    (0.91)
    0.2
    (0.77)
    120 Hours
    -0.8
    (1.02)
    -0.2
    (0.86)
    14. Secondary Outcome
    Title Change From Baseline in Serum Potassium by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    6 Hours
    -0.4
    (0.62)
    -0.1
    (0.56)
    12 Hours
    -0.4
    (0.66)
    -0.1
    (0.51)
    18 Hours
    -0.7
    (0.68)
    -0.1
    (0.43)
    24 Hours
    -0.9
    (0.75)
    -0.2
    (0.49)
    30 Hours
    -0.9
    (0.7)
    -0.1
    (0.67)
    36 Hours
    -1.0
    (0.81)
    -0.0
    (0.69)
    42 Hours
    -1.0
    (0.68)
    -0.0
    (0.58)
    48 Hours
    -1.0
    (0.62)
    -0.0
    (0.54)
    54 Hours
    -1.2
    (0.61)
    0.1
    (0.65)
    60 Hours
    -1.2
    (0.76)
    0.1
    (0.54)
    66 Hours
    -1.2
    (0.81)
    0.3
    (0.58)
    72 Hours
    -1.2
    (0.69)
    0.2
    (0.83)
    78 Hours
    -1.2
    (0.75)
    0.1
    (0.68)
    84 Hours
    -1.3
    (0.77)
    0.2
    (0.65)
    90 Hours
    -1.4
    (0.71)
    0.2
    (0.75)
    96 Hours
    -1.1
    (0.85)
    0.2
    (0.82)
    102 Hours
    -1.2
    (0.72)
    0
    (0.73)
    108 Hours
    -1.2
    (0.76)
    0.1
    (0.86)
    114 Hours
    -1.5
    (0.8)
    0.2
    (0.85)
    120 Hours
    -1.1
    (0.63)
    0.1
    (0.75)
    15. Secondary Outcome
    Title Change From Baseline in Serum Chloride by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    6 Hours
    -1.9
    (4.12)
    0.6
    (3.1)
    12 Hours
    -3.4
    (4.23)
    0.9
    (3.44)
    18 Hours
    -3.9
    (5.67)
    0.8
    (3.52)
    24 Hours
    -3.9
    (6.58)
    1.3
    (5.04)
    30 Hours
    -5.5
    (6.84)
    1.1
    (4.59)
    36 Hours
    -5.0
    (6.73)
    0.6
    (4.44)
    42 Hours
    -4.9
    (7.31)
    0.5
    (4.5)
    48 Hours
    -5.1
    (7.35)
    1.3
    (4.44)
    54 Hours
    -5.4
    (7.39)
    0.9
    (4.91)
    60 Hours
    -5.9
    (7.68)
    1
    (4.79)
    66 Hours
    -5.3
    (7.82)
    1
    (4.94)
    72 Hours
    -5.6
    (7.61)
    1.7
    (4.38)
    78 Hours
    -5.5
    (7.4)
    2.4
    (4.45)
    84 Hours
    -5.8
    (6.76)
    2.1
    (5.33)
    90 Hours
    -5.9
    (7.68)
    2.3
    (5.1)
    96 Hours
    -6.2
    (7.69)
    2.4
    (4.64)
    102 Hours
    -6.0
    (7.51)
    2.6
    (6.02)
    108 Hours
    -5.9
    (7.88)
    1.3
    (4.42)
    114 Hours
    -7.7
    (8.63)
    1.1
    (5.96)
    120 Hours
    -8.1
    (6.28)
    1
    (5.89)
    16. Secondary Outcome
    Title Number of Participants With Bleeding Events
    Description
    Time Frame Up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    0 Bleeding Events
    16
    94.1%
    13
    76.5%
    1 Bleeding Events
    1
    5.9%
    3
    17.6%
    2 Bleeding Events
    0
    0%
    0
    0%
    4 Bleeding Events
    0
    0%
    1
    5.9%
    17. Secondary Outcome
    Title Number of Participants by Number of Blood Transfusions
    Description
    Time Frame Up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    3 Transfusions
    1
    5.9%
    2
    11.8%
    27 Transfusions
    0
    0%
    1
    5.9%
    18. Secondary Outcome
    Title Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious)
    Description
    Time Frame Up to 30 days post study CRRT treatment completion

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    Number [Events]
    0
    1
    19. Secondary Outcome
    Title Change From Baseline in Blood Pressure at Last Visit
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    Systolic
    1.9
    (25.37)
    -6.4
    (30.99)
    Diastolic
    -2.8
    (12.29)
    2.8
    (21.19)
    20. Secondary Outcome
    Title Change From Baseline in Respiratory Rate at Last Visit
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    Mean (Standard Deviation) [breaths/Min]
    -2.1
    (5.42)
    -1.1
    (7.64)
    21. Secondary Outcome
    Title Change From Baseline in Temperature at Last Visit
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    Mean (Standard Deviation) [degree celsius]
    0.2
    (0.69)
    -0.1
    (1.12)
    22. Secondary Outcome
    Title Change From Baseline in Pulse at Last Visit
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    Mean (Standard Deviation) [beats/min]
    2.1
    (24.66)
    3.2
    (16.52)
    23. Secondary Outcome
    Title Change From Baseline in Total Calcium/iCa Ratio by Hour
    Description
    Time Frame Baseline and up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    1 Hour
    0.2
    (0.25)
    -0.1
    (0.12)
    6 Hours
    0.2
    (0.17)
    -0.1
    (0.12)
    12 Hours
    0.2
    (0.18)
    -0.1
    (0.12)
    18 Hours
    0.2
    (0.13)
    -0.1
    (0.1)
    24 Hours
    0.3
    (0.25)
    -0.1
    (0.08)
    30 Hours
    0.2
    (0.16)
    -0.1
    (0.09)
    36 Hours
    0.2
    (0.14)
    -0.1
    (0.08)
    42 Hours
    0.3
    (0.21)
    -0.1
    (0.08)
    48 Hours
    0.2
    (0.2)
    -0.1
    (0.07)
    54 Hours
    0.2
    (0.18)
    -0.1
    (0.1)
    60 Hours
    0.2
    (0.16)
    -0.1
    (0.09)
    66 Hours
    0.2
    (0.19)
    -0.1
    (0.09)
    72 Hours
    0.2
    (0.16)
    -0.1
    (0.1)
    78 Hours
    0.2
    (0.23)
    -0.1
    (0.13)
    84 Hours
    0.2
    (0.18)
    -0.1
    (0.09)
    90 Hours
    0.2
    (0.18)
    -0.1
    (0.11)
    96 Hours
    0.2
    (0.2)
    -0.1
    (0.11)
    102 Hours
    0.2
    (0.2)
    -0.1
    (0.11)
    108 Hours
    0.2
    (0.19)
    -0.1
    (0.14)
    114 Hours
    0.1
    (0.17)
    -0.1
    (0.11)
    120 Hours
    0.2
    (0.14)
    -0.1
    (0.09)
    24. Secondary Outcome
    Title Number of Bleeding Events by Location
    Description
    Time Frame Up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    Gastrointestinal
    1
    4
    M150 filter
    0
    1
    ostomy and rectum
    0
    1
    upper Gastrointestinal tract
    0
    1
    25. Secondary Outcome
    Title Duration of Bleeding Events
    Description
    Time Frame Up to 120 hours post CRRT treatment initiation

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    Measure Participants 17 17
    Mean (Standard Deviation) [Hours]
    0
    (0)
    14.4
    (12.71)

    Adverse Events

    Time Frame Up to 120 hours post CRRT treatment initiation
    Adverse Event Reporting Description
    Arm/Group Title Prismocitrate 18 No Systemic Anticoagulation
    Arm/Group Description CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
    All Cause Mortality
    Prismocitrate 18 No Systemic Anticoagulation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/17 (47.1%) 9/17 (52.9%)
    Serious Adverse Events
    Prismocitrate 18 No Systemic Anticoagulation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/17 (58.8%) 10/17 (58.8%)
    Cardiac disorders
    Cardiac arrest 1/17 (5.9%) 1 2/17 (11.8%) 3
    Cardio-respiratory arrest 0/17 (0%) 0 2/17 (11.8%) 2
    Cardiogenic shock 0/17 (0%) 0 1/17 (5.9%) 1
    Nodal arrhythmia 0/17 (0%) 0 1/17 (5.9%) 1
    Gastrointestinal disorders
    Intestinal perforation 1/17 (5.9%) 1 0/17 (0%) 0
    Upper gastrointestinal haemorrhage 0/17 (0%) 0 1/17 (5.9%) 1
    General disorders
    Cardiac death 0/17 (0%) 0 2/17 (11.8%) 2
    Death 1/17 (5.9%) 1 0/17 (0%) 0
    Infections and infestations
    Fungaemia 1/17 (5.9%) 1 0/17 (0%) 0
    Sepsis 1/17 (5.9%) 1 0/17 (0%) 0
    Septic shock 4/17 (23.5%) 5 2/17 (11.8%) 2
    Injury, poisoning and procedural complications
    Endotracheal intubation complication 0/17 (0%) 0 1/17 (5.9%) 1
    Fall 1/17 (5.9%) 1 0/17 (0%) 0
    Investigations
    Blood lactic acid increased 0/17 (0%) 0 1/17 (5.9%) 1
    Blood pH decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Haematocrit decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Metabolism and nutrition disorders
    Hyperkalaemia 0/17 (0%) 0 1/17 (5.9%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma cell myeloma 1/17 (5.9%) 1 0/17 (0%) 0
    Nervous system disorders
    Cerebrovascular accident 0/17 (0%) 0 1/17 (5.9%) 1
    Renal and urinary disorders
    Acute kidney injury 0/17 (0%) 0 1/17 (5.9%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 3/17 (17.6%) 3 1/17 (5.9%) 1
    Respiratory failure 1/17 (5.9%) 1 0/17 (0%) 0
    Vascular disorders
    Hypovolaemic shock 0/17 (0%) 0 1/17 (5.9%) 1
    Peripheral ischaemia 1/17 (5.9%) 1 0/17 (0%) 0
    Other (Not Including Serious) Adverse Events
    Prismocitrate 18 No Systemic Anticoagulation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/17 (76.5%) 14/17 (82.4%)
    Blood and lymphatic system disorders
    Anaemia 2/17 (11.8%) 2 2/17 (11.8%) 2
    Thrombocytopenia 1/17 (5.9%) 1 0/17 (0%) 0
    Cardiac disorders
    Arrhythmia 0/17 (0%) 0 1/17 (5.9%) 1
    Atrial fibrillation 6/17 (35.3%) 6 1/17 (5.9%) 1
    Atrial flutter 1/17 (5.9%) 1 0/17 (0%) 0
    Bradycardia 0/17 (0%) 0 1/17 (5.9%) 1
    Tachycardia 0/17 (0%) 0 1/17 (5.9%) 1
    Ventricular tachycardia 1/17 (5.9%) 1 0/17 (0%) 0
    Congenital, familial and genetic disorders
    Hypophosphatasia 0/17 (0%) 0 1/17 (5.9%) 1
    Eye disorders
    Macular degeneration 0/17 (0%) 0 1/17 (5.9%) 1
    Gastrointestinal disorders
    Diarrhoea 1/17 (5.9%) 1 0/17 (0%) 0
    Dysphagia 0/17 (0%) 0 1/17 (5.9%) 1
    Faecaloma 0/17 (0%) 0 1/17 (5.9%) 1
    Gastrointestinal haemorrhage 0/17 (0%) 0 1/17 (5.9%) 1
    Haematemesis 0/17 (0%) 0 1/17 (5.9%) 1
    Nausea 1/17 (5.9%) 1 0/17 (0%) 0
    General disorders
    Eye complication associated with device 0/17 (0%) 0 1/17 (5.9%) 1
    Fatigue 1/17 (5.9%) 1 1/17 (5.9%) 1
    Oedema 0/17 (0%) 0 1/17 (5.9%) 1
    Pyrexia 1/17 (5.9%) 1 0/17 (0%) 0
    Therapeutic response decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Immune system disorders
    Drug hypersensitivity 1/17 (5.9%) 1 0/17 (0%) 0
    Infections and infestations
    Pneumonia 1/17 (5.9%) 1 1/17 (5.9%) 1
    Postoperative wound infection 0/17 (0%) 0 1/17 (5.9%) 1
    Urinary tract infection 1/17 (5.9%) 1 0/17 (0%) 0
    Injury, poisoning and procedural complications
    Skin wound 0/17 (0%) 0 1/17 (5.9%) 1
    Investigations
    Blood bicarbonate decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Blood bilirubin increased 0/17 (0%) 0 1/17 (5.9%) 1
    Blood chloride decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Blood lactic acid increased 0/17 (0%) 0 1/17 (5.9%) 1
    Blood phosphorus decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Blood pressure decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Haematocrit decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Haemoglobin decreased 0/17 (0%) 0 1/17 (5.9%) 2
    Hepatic enzyme abnormal 0/17 (0%) 0 1/17 (5.9%) 1
    PCO2 decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Radial pulse abnormal 1/17 (5.9%) 1 0/17 (0%) 0
    White blood cell count increased 0/17 (0%) 0 1/17 (5.9%) 1
    Metabolism and nutrition disorders
    Acidosis 1/17 (5.9%) 1 0/17 (0%) 0
    Hyperglycaemia 1/17 (5.9%) 1 0/17 (0%) 0
    Hyperkalaemia 1/17 (5.9%) 1 1/17 (5.9%) 1
    Hypocalcaemia 1/17 (5.9%) 1 0/17 (0%) 0
    Hypoglycaemia 0/17 (0%) 0 3/17 (17.6%) 4
    Hypokalaemia 2/17 (11.8%) 2 0/17 (0%) 0
    Hypomagnesaemia 3/17 (17.6%) 3 0/17 (0%) 0
    Hypophosphataemia 2/17 (11.8%) 2 4/17 (23.5%) 4
    Hypovolaemia 1/17 (5.9%) 1 0/17 (0%) 0
    Ketoacidosis 1/17 (5.9%) 1 0/17 (0%) 0
    Lactic acidosis 1/17 (5.9%) 1 1/17 (5.9%) 1
    Nervous system disorders
    Hypoaesthesia 1/17 (5.9%) 1 0/17 (0%) 0
    Unresponsive to stimuli 0/17 (0%) 0 1/17 (5.9%) 1
    Psychiatric disorders
    Anxiety 1/17 (5.9%) 1 0/17 (0%) 0
    Renal and urinary disorders
    Anuria 0/17 (0%) 0 1/17 (5.9%) 1
    Haematuria 1/17 (5.9%) 1 0/17 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/17 (0%) 0 1/17 (5.9%) 1
    Epistaxis 1/17 (5.9%) 1 0/17 (0%) 0
    Hypercapnia 1/17 (5.9%) 1 0/17 (0%) 0
    Rales 0/17 (0%) 0 1/17 (5.9%) 1
    Respiratory distress 0/17 (0%) 0 1/17 (5.9%) 1
    Respiratory tract oedema 1/17 (5.9%) 1 0/17 (0%) 0
    Skin and subcutaneous tissue disorders
    Blister 0/17 (0%) 0 1/17 (5.9%) 1
    Erythema multiforme 1/17 (5.9%) 1 0/17 (0%) 0
    Vascular disorders
    Axillary vein thrombosis 1/17 (5.9%) 1 0/17 (0%) 0
    Haemorrhage 0/17 (0%) 0 1/17 (5.9%) 1
    Hypertension 0/17 (0%) 0 1/17 (5.9%) 1
    Hypotension 0/17 (0%) 0 3/17 (17.6%) 3

    Limitations/Caveats

    The study was terminated as it was proven to be extremely difficult to enroll patients. The study termination decision was unrelated to safety or efficacy. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.

    Results Point of Contact

    Name/Title Baxter Clinical Trials Disclosure Call Center
    Organization Baxter Healthcare
    Phone (224) 948-7359
    Email Global_CORP_ClinicalTrialsDisclosure@baxter.com
    Responsible Party:
    Baxter Healthcare Corporation
    ClinicalTrials.gov Identifier:
    NCT02860130
    Other Study ID Numbers:
    • 1407-004
    First Posted:
    Aug 9, 2016
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020