Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration (IBPS)

March 31, 2022 updated by: Peter Van Buren, University of Texas Southwestern Medical Center

Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial

This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. It also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • DaVita Dialysis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than 18 years
  • End Stage Renal Disease on Maintenance Hemodialysis
  • Hypertension defined as systolic blood pressure > 140 mmHg pre-dialysis or >130 mmHg post dialysis

Exclusion Criteria:

  • Hemodialysis Vintage < 1 month
  • Pregnancy
  • Nadir Systolic Blood Pressure < 95 mmHg
  • Pre or Post dialysis systolic blood pressure > 180 mmHg
  • Decrease in systolic blood pressure >60 mmHg from pre to post dialysis
  • Ultrafiltration rate >13 mL/kg/hr
  • Peridialytic Midodrine Use
  • Intradialytic Clonidine use
  • Documented Antihypertensive Medication Non-adherence

Bioimpedance will not be peformed on patients with

  • amputated arms or legs
  • cardiac defibrillator or pacemaker
  • presence of metal prostheses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
Experimental: IBPS Group
This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.
Other: Intradialytic Blood Pressure Slope Based Ultrafiltration
Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Ambulatory Systolic Blood Pressure
Time Frame: Baseline, 4 months
The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
Baseline, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Extracellular Volume/Body Weight Ratio
Time Frame: Baseline, 4 months
expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month
Baseline, 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Peter Van Buren, MD, MSCS, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 032017-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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