Ethanol in the Prevention of Central Venous Catheter Infections
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- catheter infectionrelated incidence rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]decrease on catheter infection related incidence rates in comparison to the institution incidence figures
- cathether bacteriaemia related rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]versus Institution rate figures
- antimicrobial consume [ Time Frame: 2 years ] [ Designated as safety issue: No ]Defined Diary Dosis(DDDs)in both arms
|Study Start Date:||December 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Every three day lock using Ethanol in all the lumen of the Catheter
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
Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229592
|Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon|
|Madrid, Spain, 28007|