Trial Outcomes & Findings for Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration (NCT NCT03303391)
NCT ID: NCT03303391
Last Updated: 2022-08-25
Results Overview
The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Baseline, 4 months
Results posted on
2022-08-25
Participant Flow
Participant milestones
| Measure |
Standard Care
This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
|
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
|
Overall Study
COMPLETED
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 intervention subjects withdrew prior to study intervention starting
Baseline characteristics by cohort
| Measure |
Standard Care
n=9 Participants
This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
|
IBPS Group
n=3 Participants
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
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • 2 intervention subjects withdrew prior to study intervention starting
|
0 Participants
n=7 Participants • 2 intervention subjects withdrew prior to study intervention starting
|
0 Participants
n=5 Participants • 2 intervention subjects withdrew prior to study intervention starting
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants • 2 intervention subjects withdrew prior to study intervention starting
|
2 Participants
n=7 Participants • 2 intervention subjects withdrew prior to study intervention starting
|
10 Participants
n=5 Participants • 2 intervention subjects withdrew prior to study intervention starting
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants • 2 intervention subjects withdrew prior to study intervention starting
|
1 Participants
n=7 Participants • 2 intervention subjects withdrew prior to study intervention starting
|
2 Participants
n=5 Participants • 2 intervention subjects withdrew prior to study intervention starting
|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 11 • n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
57.3 years
STANDARD_DEVIATION 13 • n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
54.6 years
STANDARD_DEVIATION 11 • n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
2 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
5 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
1 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
7 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
1 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
6 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
2 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
6 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
2 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
6 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
1 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
6 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
0 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
3 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
12 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
|
Diabetes
|
6 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
3 Participants
n=7 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
9 Participants
n=5 Participants • Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
|
PRIMARY outcome
Timeframe: Baseline, 4 monthsThe change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
Outcome measures
| Measure |
Standard Care
n=9 Participants
This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
|
IBPS Group
n=3 Participants
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
|
|---|---|---|
|
Change in Mean Ambulatory Systolic Blood Pressure
|
-0.9 mmHg
Standard Deviation 12
|
-21.3 mmHg
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline, 4 monthsPopulation: 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.
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
Outcome measures
| Measure |
Standard Care
n=6 Participants
This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
|
IBPS Group
n=3 Participants
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
|
|---|---|---|
|
Change in Extracellular Volume/Body Weight Ratio
|
-0.003 L/kg
Standard Deviation .02
|
-.01 L/kg
Standard Deviation .007
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
IBPS Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Care
n=9 participants at risk
This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
|
IBPS Group
n=3 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Intradialytic Hypotension
|
55.6%
5/9 • Number of events 10 • Adverse events were determined over a 4 month period per subject
|
100.0%
3/3 • Number of events 11 • Adverse events were determined over a 4 month period per subject
|
Additional Information
Peter Van Buren
University of Texas Southwestern Medical Center
Phone: 214-645-8293
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place