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Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration (IBPS)

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ClinicalTrials.gov Identifier: NCT03303391
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Peter Van Buren, University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ESRD Extracellular Fluid Alteration Hypertension Other: Intradialytic Blood Pressure Slope Based Ultrafiltration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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




Primary Outcome Measures :
  1. Ambulatory Systolic Blood Pressure [ Time Frame: 4 months ]
    expected reduction of at least 3 mmHg greater reduction for IBPS compared to standard care


Secondary Outcome Measures :
  1. Extracellular Volume/Body Weight Ratio [ Time Frame: 4 months ]
    expected reduction of at least 0.025 greater reduction for IBPS compared to standard care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303391


Contacts
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Contact: Peter Van Buren, MD, MSCS 214-645-8293 peter.vanburen@utsouthwestern.edu

Locations
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United States, Texas
Davita Dialysis Recruiting
Dallas, Texas, United States, 75390
Contact: PETER VAN BUREN    214-645-8293    peter.vanburen@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Peter Van Buren, MD, MSCS University of Texas Southwestern Medical Center
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Responsible Party: Peter Van Buren, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03303391    
Other Study ID Numbers: STU 032017-024
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases