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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am on hemodialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ambulatory Systolic Blood Pressure
Secondary outcome measures
Association Between intradialytic blood pressure slope with systolic and diastolic dysfunction
Extracellular Volume
Intradialytic Hypotension
+1 moreTrial 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,384 Total Patients Enrolled
Peter Noel Van Buren, MDPrincipal InvestigatorVA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure before or after dialysis is consistently higher than 180 mmHg.I have not consistently taken my blood pressure medication as prescribed.I have been on hemodialysis for less than 2 months.I regularly use clonidine during dialysis.I have an amputation, a cardiac device, or a metallic implant.I regularly take midodrine during dialysis.I am on hemodialysis.Your average lowest blood pressure reading is less than 95 mmHg during the 2-week screening period.Your blood pressure drops by more than 60 points from before to after hemodialysis.Your kidneys filter fluid too quickly.My average blood pressure before or after dialysis is above the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: IBPS (Intradialytic Blood Pressure Slope) Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for participants in this study?
"The clinical trial is currently accepting applicants, as detailed on the clinicaltrials.gov website. This examination was posted initially on February 10th 2021 and most recently revised on January 21st 2022."
Answered by AI
How many human participants are being analyzed in this investigation?
"Affirmative. The information on clinicaltrials.gov indicates that recruitment is currently underway for this trial, which was initially launched on February 10th 2021 and revised most recently on January 21st 2022. Specifically, 69 people are required at one medical site to complete the study."
Answered by AI
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