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Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration (IBPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03303391
Recruitment Status : Terminated (Funding Expired)
First Posted : October 6, 2017
Results First Posted : August 25, 2022
Last Update Posted : August 25, 2022
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)
Actual Enrollment : 14 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
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2020

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. 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)


Secondary Outcome Measures :
  1. 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



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


Locations
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United States, Texas
Davita Dialysis
Dallas, Texas, United States, 75390
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
  Study Documents (Full-Text)

Documents provided by Peter Van Buren, 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
Results First Posted: August 25, 2022
Last Update Posted: August 25, 2022
Last Verified: March 2022
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