Ethanol in the Prevention of Central Venous Catheter Infections

Not Applicable

Terminated

• Conditions: Catheter Related Infection
• Interventions: Drug: Ethanol; Drug: Heparine

• Registration Number: NCT01229592
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ethanol	Ethanol	Every three day lock using Ethanol in all the lumen of the Catheter
Heparine	Heparine	Every three day lock using Heparine in all the lumen of the Catheter

Primary Outcome Measures

Name	Time	Method
catheter infectionrelated incidence rates	2 years	decrease on catheter infection related incidence rates in comparison to the institution incidence figures

Secondary Outcome Measures

Name	Time	Method
cathether bacteriaemia related rate	2 years	versus Institution rate figures
antimicrobial consume	2 years	Defined Diary Dosis(DDDs)in both arms

Trial Locations

Locations (1)

Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon; 🇪🇸 Madrid, Spain