Comparison of ethanol lock vs heparin lock in catheter infection treatment
Phase 2
- Conditions
- Health Condition 1: Z992- Dependence on renal dialysisHealth Condition 2: N186- End stage renal diseaseHealth Condition 3: T802- Infections following infusion, transfusion and therapeutic injection
- Registration Number
- CTRI/2023/06/053826
- Lead Sponsor
- Vignesh Subramani
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•Adult patients more than equal to 18 years of age
•Incident hemodialysis patients with tunnelled internal jugular central venous catheters
•Able to give informed consent
•Documented catheter-related bloodstream infection
Exclusion Criteria
1) Personal, cultural, or other objections to the use of alcohol as a catheter lock
2) Intolerance to alcohol
3) Patients on disulfiram
4) Pregnant/ breastfeeding patients
5) Evidence of metastatic infection such as infective endocarditis, lung abscess, septic emboli, and septic arthritis.
6) Fungal growth on blood culture
7) Catheter-related exit site or tunnel infection
8) Hemodynamically unstable Patient (shock) that warrants immediate catheter removal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with clinical cure and catheter salvage at the end of day 6 ( on the day of completion of lock treatment )Timepoint: day 6
- Secondary Outcome Measures
Name Time Method Microbiological profile as assessed by the type of organism in the culture and its sensitivity patternTimepoint: Day 6;Preservation of the tunnelled catheter lineTimepoint: Day 30;Recurrence of catheter-related blood stream infectionTimepoint: Day 30;Safety and tolerability profile as assessed by adverse events, serious adverse events, vital signs, clinical laboratory evaluations, and physical examinations.Timepoint: Day 30;The proportion of subjects with Microbiological Eradication with negative blood cultureTimepoint: Day 6