IBPS: Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration
Study Details
Study Description
Brief Summary
This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. It also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Standard Care This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist |
|
Experimental: IBPS Group This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. |
Other: Intradialytic Blood Pressure Slope Based Ultrafiltration
Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments
|
Outcome Measures
Primary Outcome Measures
- Change in Mean Ambulatory Systolic Blood Pressure [Baseline, 4 months]
The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
Secondary Outcome Measures
- Change in Extracellular Volume/Body Weight Ratio [Baseline, 4 months]
expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age greater than 18 years
-
End Stage Renal Disease on Maintenance Hemodialysis
-
Hypertension defined as systolic blood pressure > 140 mmHg pre-dialysis or >130 mmHg post dialysis
Exclusion Criteria:
-
Hemodialysis Vintage < 1 month
-
Pregnancy
-
Nadir Systolic Blood Pressure < 95 mmHg
-
Pre or Post dialysis systolic blood pressure > 180 mmHg
-
Decrease in systolic blood pressure >60 mmHg from pre to post dialysis
-
Ultrafiltration rate >13 mL/kg/hr
-
Peridialytic Midodrine Use
-
Intradialytic Clonidine use
-
Documented Antihypertensive Medication Non-adherence
Bioimpedance will not be peformed on patients with
-
amputated arms or legs
-
cardiac defibrillator or pacemaker
-
presence of metal prostheses
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Davita Dialysis | Dallas | Texas | United States | 75390 |
Sponsors and Collaborators
- University of Texas Southwestern Medical Center
Investigators
- Principal Investigator: Peter Van Buren, MD, MSCS, University of Texas Southwestern Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- STU 032017-024
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Standard Care | IBPS Group |
---|---|---|
Arm/Group Description | This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist | This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments |
Period Title: Overall Study | ||
STARTED | 9 | 3 |
COMPLETED | 9 | 3 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Standard Care | IBPS Group | Total |
---|---|---|---|
Arm/Group Description | This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist | This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments | Total of all reporting groups |
Overall Participants | 9 | 3 | 12 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
8
88.9%
|
2
66.7%
|
10
83.3%
|
>=65 years |
1
11.1%
|
1
33.3%
|
2
16.7%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
53.4
(11)
|
57.3
(13)
|
54.6
(11)
|
Sex: Female, Male (Count of Participants) | |||
Female |
3
33.3%
|
2
66.7%
|
5
41.7%
|
Male |
6
66.7%
|
1
33.3%
|
7
58.3%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
5
55.6%
|
1
33.3%
|
6
50%
|
Not Hispanic or Latino |
4
44.4%
|
2
66.7%
|
6
50%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
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 |
4
44.4%
|
2
66.7%
|
6
50%
|
White |
5
55.6%
|
1
33.3%
|
6
50%
|
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 |
9
100%
|
3
100%
|
12
100%
|
Diabetes (Count of Participants) | |||
Count of Participants [Participants] |
6
66.7%
|
3
100%
|
9
75%
|
Outcome Measures
Title | Change in Mean Ambulatory Systolic Blood Pressure |
---|---|
Description | The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months) |
Time Frame | Baseline, 4 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Standard Care | IBPS Group |
---|---|---|
Arm/Group Description | This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist | This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments |
Measure Participants | 9 | 3 |
Mean (Standard Deviation) [mmHg] |
-0.9
(12)
|
-21.3
(6.7)
|
Title | Change in Extracellular Volume/Body Weight Ratio |
---|---|
Description | expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month |
Time Frame | Baseline, 4 months |
Outcome Measure Data
Analysis Population Description |
---|
In the Standard of Care arm/ group, it was not possible to obtain these measurements in 3 subjects (amputations, defibrillators, implanted metal) and are missing the data since they were unable to undergo these measurements. |
Arm/Group Title | Standard Care | IBPS Group |
---|---|---|
Arm/Group Description | This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist | This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments |
Measure Participants | 6 | 3 |
Mean (Standard Deviation) [L/kg] |
-0.003
(.02)
|
-.01
(.007)
|
Adverse Events
Time Frame | Adverse events were determined over a 4 month period per subject | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Standard Care | IBPS Group | ||
Arm/Group Description | This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist | This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments | ||
All Cause Mortality |
||||
Standard Care | IBPS Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/9 (0%) | 0/3 (0%) | ||
Serious Adverse Events |
||||
Standard Care | IBPS Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/9 (0%) | 0/3 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Standard Care | IBPS Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/9 (55.6%) | 3/3 (100%) | ||
Blood and lymphatic system disorders | ||||
Intradialytic Hypotension | 5/9 (55.6%) | 10 | 3/3 (100%) | 11 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Peter Van Buren |
---|---|
Organization | University of Texas Southwestern Medical Center |
Phone | 214-645-8293 |
peter.vanburen@utsouthwestern.edu |
- STU 032017-024