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Comparison of ethanol lock vs heparin lock in catheter infection treatment

Randomised Double-Blinded Controlled Clinical Trial To Compare 70% Ethanol With Heparin Lock To Heparin Lock Alone As An Adjunct To Systemic Antibiotics For The Treatment Of Tunnelled Jugular Catheter-Related Bloodstream Infections In Patients Undergoing Hemodialysis. - Nill

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053826
Enrollment
44
Registered
2023-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: Z992- Dependence on renal dialysis Health Condition 2: N186- End stage renal disease Health Condition 3: T802- Infections following infusion, transfusion and therapeutic injection

Interventions

Intervention1: Ethanol lock: Patients in the experimental arm will receive daily instillation of 70% ethanol (randomized and concealed) into each catheter lumen for 5 days in addition to usual care wi

Sponsors

Vignesh Subramani
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactVignesh subramani

Post graduate institute of medical education and research

jasmine227021@gmail.com

Outcome results

None listed

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