Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

NCT ID: NCT03303391

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Intradialytic Blood Pressure Slope Based Ultrafiltration

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Peter Van Buren

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Van Buren, MD, MSCS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Davita Dialysis

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU 032017-024

Identifier Type: -

Identifier Source: org_study_id