Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

Not Applicable

Terminated

• Conditions: Extracellular Fluid Alteration; Hypertension; ESRD
• Interventions: Other: Intradialytic Blood Pressure Slope Based Ultrafiltration

• Registration Number: NCT03303391
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-06
• Study Start: 2017-11-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Results First Submitted: 2021-12-21
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Results First Posted: 2022-08-25
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBPS Group	Intradialytic Blood Pressure Slope Based Ultrafiltration	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Extracellular Volume/Body Weight Ratio	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

Trial Locations

Locations (1)

Davita Dialysis; 🇺🇸 Dallas, Texas, United States