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Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

NCT04163614 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-01-07

No results posted yet for this study

Summary

Kidney failure has been recognized as one of the most costly chronic conditions among United States Veterans. Approximately 13,000 Veterans develop kidney failure each year, and most require hemodialysis initiation. Hemodialysis patients suffer significantly increased risk of death and hospitalizations, and excessive body fluid is a major cause of this. While empiric aggressive fluid removal during dialysis is one approach to limit fluid overload, this can cause dangerous decreases in blood pressure during dialysis that independently contribute to the high death rate. In this study, I aim to test a new strategy that prescribes fluid removal based on a patient's recent blood pressure patterns during dialysis. This clinical trial will compare my strategy to standard care and assess the outcomes of overall blood pressure change between dialysis treatments in addition to the number of times the blood pressure becomes dangerously low during dialysis. Another aim is to determine how differences in the structure and function of the heart influence blood pressure during dialysis.

Conditions

Interventions

OTHER

IBPS-Guided Ultrafiltration

Each month, the study investigator will review the average intradialytic blood pressure slope from the prior two weeks. A prespecified algorithm will be used to prescribe additional fluid removal/weight reduction based on this slope.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Peter Noel Van Buren, MD · VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163614 on ClinicalTrials.gov