Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04163614

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Treatment

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

Loading map...

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

Similar Trials

"Smart Family Doctor" Assisted Comprehensive Management of S...

Post Coronary Artery Bypass Grafting

Actively Recruiting

1 location

The PILI 'Aina Project to Improve Cardiometabolic Health in...

Type 2 Diabetes

Actively Recruiting

2 locations

Vascular Function in Health and Disease: Rehabilitation for ...

Chronic Obstructive Pulmonary Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here