NCT01229592

Ethanol in the Prevention of Central Venous Catheter Infections

Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Catheter Related Infection

Interventions

Type	Name	Description
DRUG	Ethanol	Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter
DRUG	Heparine	Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-10-28
• Last updated: 2012-07-17

Locations

1 site across 1 country: Spain