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Cardiac safety of different fluid removal methods in patients on maintenance hemodialysis

A pilot trial to assess the effect of ultrafiltration profiling on myocardial injury markers in patients on maintenance hemodialysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049618
Enrollment
40
Registered
2023-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: Testing pre- and post- dialysis high-sensitivity troponin I in two different ultrafiltration settings commonly used in maintenance hemodialysis: All the patients will be dialysed using

Sponsors

Dr Namrata Rao S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactShivani Kanwal

Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow

snamratarao@yahoo.co.in09454360872

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026