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RANDOMISED CONTROLLED TRIAL TO COMPARE THE EFFICACY of 70% ETHANOL VERSUS HEPARIN LOCK FOR THE PREVENTION OF TUNNELLED CATHETER-RELATED BLOODSTREAM INFECTIONS IN PATIENTS UNDERGOING HEMODIALYSIS.

A DOUBLE-BLINDED RANDOMISED CONTROLLED TRIAL TO COMPARE THE EFFICACY of 70% ETHANOL VERSUS HEPARIN LOCK FOR THE PREVENTION OF TUNNELLED CATHETER-RELATED BLOODSTREAM INFECTIONS IN PATIENTS UNDERGOING HEMODIALYSIS. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080416
Enrollment
80
Registered
2025-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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: 70 % Ethanol: Patients in the experimental arm will receive weekly catheter instillation of intravenous-grade 70% ethanol for 48 hours (for patients on thrice weekly hemodialysis) and 7

Sponsors

Dr Vishal Mangal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Incident and prevalent hemodialysis patients with tunnelled jugular venous catheters who are hemodynamically stable. Patients on twice weekly or thrice weekly hemodialysis Able to give informed consent No documented catheter-related bloodstream infection or exit site infection ever after catheter insertion in last three months

Exclusion criteria

Exclusion criteria: 1. Personal, cultural, or other objections to the use of alcohol as a catheter lock 2. Patients of femoral/subclavian tunneled catheters 3. Intolerance to alcohol 4. Patients on disulfiram 5. Pregnant/ breastfeeding patients 6. History of exit site infection or CRBSI associated with the current catheter in the last three months before inclusion into the study.

Design outcomes

Primary

MeasureTime frame
1.Time to first episode of CRBSITimepoint: follow up of 8 weeks

Secondary

MeasureTime frame
1. Time to exit site infection 2. Time to infection-related catheter removal 3. Safety and tolerance profile of alcohol like dizziness, headache, vomiting and derangement of liver enzymes will be studied. 4. Catheter dysfunction Timepoint: Participants will be followed upto 8 weeks

Countries

India

Contacts

Public ContactDr Vishal Mangal

Post Graduate Institute of Medical Education And Research

jasmine227021@gmail.com9855422270

Outcome results

None listed

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