Ethanol in the Prevention of Central Venous Catheter Infections

Study Overview
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Brief Summary
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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).

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

Conditions
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Catheter Related Infection

Intervention / Treatment
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* Drug: Ethanol
* Drug: Heparine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ethanol<br>Every three day lock using Ethanol in all the lumen of the Catheter | Drug: Ethanol<br>* Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter<br>|
| Active Comparator: Heparine<br>Every three day lock using Heparine in all the lumen of the Catheter | Drug: Heparine<br>* Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catheter infectionrelated incidence rates | decrease on catheter infection related incidence rates in comparison to the institution incidence figures | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cathether bacteriaemia related rate | versus Institution rate figures | 2 years | 
| antimicrobial consume | Defined Diary Dosis(DDDs)in both arms | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, catheter, bacteriaemia, ethanol