New Citrate Protocol With Baxter in Continuous Techniques

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Unknown status
CT.gov ID
NCT04062812
Collaborator
(none)
10
1
3.3
3

Study Details

Study Description

Brief Summary

The investigators designed a monitoring and control table of a citrate treatment on a specific monitor. This is the Baxter "Prismaflex" monitor, with 8.2 software version. Dialysis bath liquids marketed by Baxter: Biphozyl are used. Citrate liquid (1:18) Regiocit is used.

The dialysis treatment monitor (CVVHD) is programmed, with a blood / citrate pumps at a rate of 1:10 (1 ml / min of blood: 10 ml / h of dialysis fluid) The starting dose of citrate will be 3.5 mmol / l and the calcium compensation will be 100% Working hypothesis: The patient undergoing citrate anticoagulation according to the designed algorithm will respond with ion stability and pH during the treatment, in addition to achieving an effective cleaning process.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study design:

    Observational Registration of variables for analysis.

    Study population Inclusión/exclusion criteria:

    Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau Hospital with the Intensive Medicine medical team, who require citrate anticoagulation in continuous dialysis therapy and are treated with Baxter "Prismaflex" monitor.

    Patients who meet the criteria described above will be followed up in this study.

    Expected sample size:

    It is estimated that with 10 patients will be enough to achieve our goal.

    Methodology. Information sources:

    The start of the treatment with Baxter citrate will be given according to the patient's need and subject to a basic medical decision. From here the research team will enter. The investigation team will never influence the medical decision.

    Since such a treatment is started, the main investigator will assign a number to the dialysis circuit and will be followed, every six hours, for the most important variables. The rest of the variables will be collected at least once a day and according to the patient's situation.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Validation of the Protocol for the Use of Regional Anticoagulation With Baxter Citrate in Continuous Extrarenal Purification Techniques in the Critical Patient
    Actual Study Start Date :
    Aug 1, 2019
    Anticipated Primary Completion Date :
    Oct 1, 2019
    Anticipated Study Completion Date :
    Nov 9, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Dialysis flow [6 hours]

      Speed at which the dialysis fluid pump is programmed in the circuit and measured in milliliters / hour

    2. Blood flow [6 hours]

      Speed at which the blood pump is programmed in the dialysis circuit and measured in milliliters / min

    3. Citrate dose [6 hours]

      Relationship that exists between the liquid we infuse (which contains 18mmol / L citrate) and the blood pump. It is measured in mmol citrate / liter of blood

    4. Calcium dose [6 hours]

      Amount of calcium that is replenished to the patient when the dialyzed blood is returned. It is measured in%.

    Secondary Outcome Measures

    1. Filter operating hours [number of hours]

      They correspond to the hours that go from the beginning of the circuit until the end of the circuit in which the fungible is discarded. It can be several days

    2. Arterial pH [6 hours]

      Corresponds to the patient's arterial blood pH figure at the time of observation

    3. Arterial bicarbonate [6 hours]

      It is the bicarbonate figure found in arterial blood. It is measured in mmol / l.

    4. Post-filter ionic calcium [6 hours]

      Corresponds to the value of ionic calcium by taking the sample at the blood outlet of the dialysis filter. It is measured in mmol / l.

    5. Ionic Calcium Patien [6 hours]

      It is the ionic calcium value of the patient in a systemic way, preferably arterial. It is measured in mmol / l

    6. Total calcium [6 hours]

      Total calcium value. It is measured in mmol / l

    7. Total Ca / Ionic Ca Ratio [24 hours]

      Relationship between the total calcium and the ionic one of the patient

    8. Match [24 hours]

      Value of this ion in the patient. It is measured in mmol / l.

    9. Magnesium [24 hours]

      Value of this ion in the patient. It is measured in mmol / l.

    10. Sodium [24 hours]

      Value of this ion in the patient. It is measured in mmol / l.

    11. Potassium [24 hours]

      Value of this ion in the patient. It is measured in mmol / l.

    12. Urea [24 hours]

      Urea level of the patient at the time of observation

    13. Creatinine [24 hours]

      Creatinine level of the patient at the time of observation

    14. INR [24 hours]

      INR level of the patient at the time of observation

    15. Lactate [24 hours]

      Lactate level of the patient at the time of observation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau with the medical team of Intensive Medicine, who require anticoagulation with citrate in continuous dialysis therapy and are treated with the Baxter monitor.
    Exclusion Criteria:
    • Those patients who do not meet the above requirement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT04062812
    Other Study ID Numbers:
    • IIBSP-CIT-2019-34
    First Posted:
    Aug 20, 2019
    Last Update Posted:
    Aug 20, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2019