Ethanol in the Prevention of Central Venous Catheter Infections

Sponsor

Hospital General Universitario Gregorio Marañon (Other)

Overall Status

Terminated

CT.gov ID

NCT01229592

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Catheter Related Infection	Drug: Ethanol Drug: Heparine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Ethanol

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

Drug: Ethanol

Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter

Active Comparator: Heparine

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

Drug: Heparine

Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter

Outcome Measures

Primary Outcome Measures

catheter infectionrelated incidence rates [2 years]
decrease on catheter infection related incidence rates in comparison to the institution incidence figures