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IBPS-Guided Ultrafiltration for Kidney Failure

N/A

Recruiting

Led By Peter Noel Van Buren, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hemodialysis patient

Be older than 18 years old

Must not have

Documented antihypertensive medication non-adherence

Routine intradialytic clonidine use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new strategy for fluid removal during dialysis that is based on a patient's recent blood pressure patterns. The goal is to compare this new strategy to standard care and assess the outcomes of overall blood pressure change between dialysis treatments.

Who is the study for?

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.

What is being tested?

The study tests a new method of removing fluid during dialysis based on patients' recent blood pressure trends compared to standard care. It aims to see if this can manage overall blood pressure better and reduce dangerous drops in blood pressure that occur during the treatment process.

What are the potential side effects?

Potential side effects may include fluctuations in blood pressure levels which could lead to episodes of very low or unstable pressures during and after the dialysis sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on hemodialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not consistently taken my blood pressure medication as prescribed.

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I regularly use clonidine during dialysis.

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I have an amputation, a cardiac device, or a metallic implant.

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I regularly take midodrine during dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ambulatory Systolic Blood Pressure

Secondary study objectives

Association Between intradialytic blood pressure slope with systolic and diastolic dysfunction

Extracellular Volume

Intradialytic Hypotension

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IBPS (Intradialytic Blood Pressure Slope) ArmExperimental Treatment1 Intervention

IBPS participants will have their target weight adjusted each month by the study investigator based on recent assessment of intradialytic blood pressure slopes.

Group II: ControlActive Control1 Intervention

Participants in the control group will have their blood pressure, fluid status, as well as all other aspects of clinical care managed in entirety by their treating nephrologists.

0 / 5Eligibility criteria met