Ethanol in the Prevention of Central Venous Catheter Infections

Hospital General Universitario Gregorio Marañon

Status: Terminated

Conditions: Catheter Related Infection

Treatments: Drug: Heparine; Drug: Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT01229592

EC07/90653

2007-007063-24 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• older than 18 years old
• Signed informed consent
• central Venous catheter more than 48 hours placed

Exclusion criteria

• pregnancy
• denial Informed consent Form
• ethanol intolerance
• Liver cirrhosis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Ethanol

Experimental group

Description:

Every three day lock using Ethanol in all the lumen of the Catheter

Treatment:

Drug: Ethanol

Heparine

Active Comparator group

Description:

Every three day lock using Heparine in all the lumen of the Catheter

Treatment:

Drug: Heparine