IBPS-Guided Ultrafiltration for Kidney Failure
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those who routinely use certain blood pressure medications during dialysis. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment IBPS-Guided Ultrafiltration for Kidney Failure?
Research shows that slow continuous ultrafiltration can be effective for patients with acute kidney failure, especially those who are unstable, as it helps manage fluid levels and blood pressure better than traditional methods. Additionally, ultrafiltration is used in heart failure patients to manage fluid overload, improving symptoms and quality of life.12345
Is IBPS-Guided Ultrafiltration generally safe for humans?
How is IBPS-Guided Ultrafiltration treatment different from other treatments for kidney failure?
IBPS-Guided Ultrafiltration is unique because it uses a noninvasive method to monitor blood volume, which can help manage fluid overload more precisely. This approach may offer greater blood pressure stability and ease of operation compared to traditional hemodialysis, especially in patients who are hemodynamically unstable (have unstable blood pressure).27101112
Research Team
Peter Noel Van Buren, MD
Principal Investigator
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Eligibility Criteria
This trial is for Veterans with kidney failure who are on hemodialysis and have high blood pressure before or after treatments. They must not be pregnant, have a pacemaker, metallic implants, or severe low blood pressure issues. Also excluded are those new to dialysis, using certain blood pressure medications during dialysis, or non-adherent to antihypertensive meds.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard care or an IBPS-based ultrafiltration prescription, with monthly adjustments based on recent intradialytic blood pressure slopes
Follow-up
Participants are monitored for changes in ambulatory systolic blood pressure and other secondary outcomes
Treatment Details
Interventions
- IBPS-Guided Ultrafiltration (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor