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Hypertension in Hemodialysis

Not Applicable
Completed
Conditions
Hypertension
Left Ventricular Hypertrophy
Interventions
Other: Ultrafiltration
Registration Number
NCT00067665
Lead Sponsor
Indiana University
Brief Summary

How high blood pressure in hemodialysis patients should be diagnosed and treated using medications or without medications is the purpose of this study.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2UltrafiltrationAll patients participating in the trial require evaluation of dry-weight at each dialysis visit for evaluation. An initial weight loss of 0.1kg/10 kg body-weight will be prescribed per dialysis. If ultrafiltration is not tolerated based on muscle cramps, need for excessive saline or symptomatic hypotension, the intensity of ultrafiltration will be reduced by 50%. If ultrafiltration is still not tolerated, the weight loss will be further reduced by 50%. If the patient cannot tolerate at least 0.2 kg incremental weight loss per dialysis, the patient will be said to be at goal dry-weight. Thus, by this protocol, all patients must experience symptoms of volume depletion to be at dry weight.
Primary Outcome Measures
NameTimeMethod
The primary outcome parameter will be systolic reduction in 44h-interdialytic ambulatory BP with ultrafiltration as compared to the control group by intention to treat analysis0, 4, 8 wks
Secondary Outcome Measures
NameTimeMethod
Per protocol analysis of primary outcome with 1. weight loss as the covariate. 2. baseline left-atrial size and weight loss as covariates.3. Others: (Description restricted by space limitation)0, 4, 8 wks

Trial Locations

Locations (1)

Indiana University Affiliated Dialysis Unit

🇺🇸

Indianapolis, Indiana, United States

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