Actively Recruiting
Using Intradialytic Blood Pressure Slopes to Guide Fluid Removal in Hemodialysis Patients A Randomized Trial Comparing Personalized Ultrafiltration to Standard Care
Led by VA Office of Research and Development · Updated on 2026-01-07
69
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research is focused on United States Veterans with end stage renal disease (ESRD) who require maintenance hemodialysis (HD). Veterans with ESRD face high rates of death and hospitalization, mainly due to cardiovascular problems linked to excess body fluid. The study aims to test a new method for fluid removal during dialysis based on monitoring patients' blood pressure patterns, comparing it to standard care. Additionally, the study will explore how heart structure and function affect blood pressure during dialysis. Participants will be randomly assigned to one of two groups. In the control group, their blood pressure and fluid status will be managed by their usual nephrologists. In the experimental group, researchers will adjust fluid removal each month using a personalized algorithm based on recent blood pressure changes during dialysis. The study will last at least four months, with monthly updates to the fluid removal plan for the experimental group. Various heart and fluid assessments will be performed, including bioimpedance and echocardiograms. During the study, participants will undergo monitoring of ambulatory blood pressure over 44 hours and assessments of fluid volume, heart resistance, and episodes of low blood pressure during dialysis. The study will also analyze heart function through echocardiograms taken on non-dialysis days. Outcomes measured include changes in blood pressure, fluid status, and frequency of low blood pressure events. The total participation time includes a four-month treatment period and additional baseline evaluations. Safety and symptom monitoring will be conducted throughout the study.
CONDITIONS
Brief Title
Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently receiving hemodialysis treatment
- Pre-dialysis systolic blood pressure greater than 140 mmHg averaged over 2 weeks OR post-dialysis systolic blood pressure greater than 130 mmHg averaged over 2 weeks
- Aged 18 years or older
You will not qualify if you...
- On hemodialysis for less than 2 months
- Pregnant
- Mean systolic blood pressure nadir less than 95 mmHg during 2 weeks screening
- Mean pre- or post-dialysis systolic blood pressure over 180 mmHg
- Mean decrease in blood pressure from pre to post dialysis greater than 60 mmHg
- Routine use of intradialytic clonidine
- Routine use of intradialytic midodrine
- Documented non-adherence to antihypertensive medication
- Mean ultrafiltration rate greater than 13 mL/kg/hr during 2 week screening
- For bioimpedance measurements only: amputation of a major extremity, presence of cardiac defibrillator or pacemaker, presence of a metallic implant such as a prosthetic joint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 4 months
Participants receive monthly ultrafiltration prescriptions based on their individual intradialytic blood pressure slopes or receive standard care managed by their nephrologists. This treatment aims to reduce blood pressure and extracellular volume safely.
Monthly visits for ultrafiltration prescription adjustments and routine hemodialysis treatments
Trial Site Locations
Total: 1 location
1
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216-7167
Actively Recruiting
Research Team
P
Peter N Van Buren, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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