drugset / Trial / NCT01229592

Ethanol in the Prevention of Central Venous Catheter Infections

NCT01229592

RandomizedParallel-groupOpen-labelPrevention

Summary

In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success \[1-10\]. Long-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of complications such as bacteremia. The need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique. Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term CVCs. Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit (HPSICU). Methods: An academic, prospective, randomized and controlled clinical trial is proposed. Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). In the follow-up period, we will register all necessary data to evaluate the end-points of study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).

Timeline

Start
2009-12
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Alcohol Other / unclassified 1 ml Other
Subject Alcohol Other / unclassified 70 % Other
Comparator Heparin Other / unclassified 3 ml Other