Catheter Related Infection Clinical Trial
Official title:
Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated 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).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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