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Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration (IBPS)

Primary Purpose

ESRD, Extracellular Fluid Alteration, Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intradialytic Blood Pressure Slope Based Ultrafiltration
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ESRD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Davita Dialysis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

IBPS Group

Arm Description

This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist

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.

Outcomes

Primary Outcome Measures

Change in Mean Ambulatory Systolic Blood Pressure
The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)

Secondary Outcome Measures

Change in Extracellular Volume/Body Weight Ratio
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

Full Information

First Posted
October 2, 2017
Last Updated
March 31, 2022
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03303391
Brief Title
Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration
Acronym
IBPS
Official Title
Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Funding Expired
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ESRD, Extracellular Fluid Alteration, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
Arm Title
IBPS Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intradialytic Blood Pressure Slope Based Ultrafiltration
Intervention Description
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 Measure Information:
Title
Change in Mean Ambulatory Systolic Blood Pressure
Description
The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
Time Frame
Baseline, 4 months
Secondary Outcome Measure Information:
Title
Change in Extracellular Volume/Body Weight Ratio
Description
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
Time Frame
Baseline, 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Van Buren, MD, MSCS
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Davita Dialysis
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

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