Ethanol in the Prevention of Central Venous Catheter Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Catheter Related Infection Drug: Ethanol Drug: Heparine

Study Type : Interventional  (Clinical Trial)
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 : December 2009
Primary Completion Date : February 2012
Study Completion Date : February 2012

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

Primary Outcome Measures :
  1. catheter infectionrelated incidence rates [ Time Frame: 2 years ]
    decrease on catheter infection related incidence rates in comparison to the institution incidence figures

Secondary Outcome Measures :
  1. cathether bacteriaemia related rate [ Time Frame: 2 years ]
    versus Institution rate figures

  2. antimicrobial consume [ Time Frame: 2 years ]
    Defined Diary Dosis(DDDs)in both arms

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01229592

Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospital General Universitario Gregorio Marañon Identifier: NCT01229592     History of Changes
Other Study ID Numbers: EC07/90653
2007-007063-24 ( EudraCT Number )
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by Hospital General Universitario Gregorio Marañon:

Additional relevant MeSH terms:
Communicable Diseases
Catheter-Related Infections
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs