Hypertension in Hemodialysis
Not Applicable
Completed
- Conditions
- HypertensionLeft 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
Group Intervention Description 2 Ultrafiltration All 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
Name Time Method 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 analysis 0, 4, 8 wks
- Secondary Outcome Measures
Name Time Method 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