Ethanol in the Prevention of Central Venous Catheter Infections
|ClinicalTrials.gov Identifier: NCT01229592|
Recruitment Status : Terminated (The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations)
First Posted : October 28, 2010
Last Update Posted : July 17, 2012
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|
|Catheter Related Infection||Drug: Ethanol Drug: Heparine|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections|
|Study Start Date :||December 2009|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
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
- catheter infectionrelated incidence rates [ Time Frame: 2 years ]decrease on catheter infection related incidence rates in comparison to the institution incidence figures
- cathether bacteriaemia related rate [ Time Frame: 2 years ]versus Institution rate figures
- antimicrobial consume [ Time Frame: 2 years ]Defined Diary Dosis(DDDs)in both arms
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229592
|Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon|
|Madrid, Spain, 28007|