Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

NCT03303391 | Terminated Results

• 1 other identifier: STU 032017-024
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

ESRD; Extracellular Fluid Alteration; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Mean Ambulatory Systolic Blood Pressure

  The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)

  Baseline, 4 months

Secondary Outcomes (1)

• Change in Extracellular Volume/Body Weight Ratio

  Baseline, 4 months

Study Arms (2)

Standard Care

NO INTERVENTION

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

IBPS Group

EXPERIMENTAL

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

Interventions

Intradialytic Blood Pressure Slope Based Ultrafiltration OTHER

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

IBPS Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Davita Dialysis

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Peter Van Buren
• Organization: University of Texas Southwestern Medical Center

peter.vanburen@utsouthwestern.edu

214-645-8293

Study Officials

• Peter Van Buren, MD, MSCS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 6, 2017
• Study Start: November 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 25, 2022
• Results First Posted: August 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)