Clinical Trial: Ethanol in the Prevention of Central Venous Catheter Infections

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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).


Detailed Summary:
Sponsor: Hospital General Universitario Gregorio Marañon

Current Primary Outcome: catheter infectionrelated incidence rates [ Time Frame: 2 years ]

decrease on catheter infection related incidence rates in comparison to the institution incidence figures


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Hospital General Universitario Gregorio Marañon

Dates:
Date Received: October 18, 2010
Date Started: December 2009
Date Completion:
Last Updated: July 16, 2012
Last Verified: July 2012