ESRD, Extracellular Fluid Alteration, Hypertension
Conditions
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.
Interventions
OTHERIntradialytic 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
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist | 9 |
| 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 | 3 |
| Total | 12 |
Baseline characteristics
| Characteristic | Standard Care | IBPS Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 2 Participants | 10 Participants |
| Age, Continuous | 53.4 years STANDARD_DEVIATION 11 | 57.3 years STANDARD_DEVIATION 13 | 54.6 years STANDARD_DEVIATION 11 |
| Diabetes | 6 Participants | 3 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 1 Participants | 6 Participants |
| Region of Enrollment United States | 9 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 3 |
| other Total, other adverse events | 5 / 9 | 3 / 3 |
| serious Total, serious adverse events | 0 / 9 | 0 / 3 |
Outcome results
Primary
Change in Mean Ambulatory Systolic Blood Pressure
The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
Time frame: Baseline, 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Mean Ambulatory Systolic Blood Pressure | -0.9 mmHg | Standard Deviation 12 |
| IBPS Group | Change in Mean Ambulatory Systolic Blood Pressure | -21.3 mmHg | Standard Deviation 6.7 |
Secondary
Change in Extracellular Volume/Body Weight Ratio
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Extracellular Volume/Body Weight Ratio | -0.003 L/kg | Standard Deviation 0.02 |
| IBPS Group | Change in Extracellular Volume/Body Weight Ratio | -.01 L/kg | Standard Deviation 0.007 |