Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

University of Texas Southwestern Medical Center14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ESRD Extracellular Fluid Alteration Hypertension

Interventions

Intradialytic Blood Pressure Slope Based UltrafiltrationOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Davita Dialysis

Dallas, Texas, United States

Outcomes

Primary Outcomes

Change in Mean Ambulatory Systolic Blood Pressure

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

Time frame: Baseline, 4 months

Secondary Outcomes

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

Time frame: Baseline, 4 months

Data from ClinicalTrials.gov

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