Cardiac safety of different fluid removal methods in patients on maintenance hemodialysis
- Conditions
- Health Condition 1: N186- End stage renal disease
- Registration Number
- CTRI/2023/02/049618
- Lead Sponsor
- Dr Namrata Rao S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients > 18 years of age, on maintenance hemodialysis > 3 months with UF removal rates of > 13 ml/kg/hour in > 3 occasions in the screening month and not receiving any UF profiling in the screening month
Active infection, hospitalization during screening month, unstable angina, NYHA Class IV heart failure, noncompliance to dialysis schedules, any requirement of > 4 dialysis sessions/week in the screening month, receiving UF and/or sodium profiling in routine HD prescription in the screening month, and intradialytic hypotension > 1 episode requiring session or ultrafiltration termination in the screening month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the changes in highly-sensitive troponin I level from pre-to post-dialysis during 4 dialysis sessions of constant ultrafiltration and 4 dialysis sessions of profiled ultrafiltration over 4 consecutive weeks, in patients of endstage renal disease with fluid overloadTimepoint: At timepoints 1-4 during week 1,2 (constant ultrafiltration) and timepoints 5-8 during week 3,4 (profiled ultrafiltration)
- Secondary Outcome Measures
Name Time Method To compare the occurrence of symptomatic intradialytic hypotension during 4 dialysis sessions of constant ultrafiltration and 4 dialysis sessions of profiled ultrafiltration over 4 consecutive weeks, in patients of endstage renal disease with fluid overloadTimepoint: At timepoints 1-4 in weeks 1,2 and timepoints 5-8 in weeks 3,4