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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01229592
Study type Interventional
Source Hospital General Universitario Gregorio Marañon
Contact
Status Terminated
Phase N/A
Start date December 2009
Completion date February 2012

See also
  Status Clinical Trial Phase
Recruiting NCT02950246 - Alcoholic Chlorhexidine Compared to Povidone Iodine to Limit Perineural Catheter Colonisation N/A
Recruiting NCT01947751 - Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock N/A
Completed NCT02563041 - Comparative Effectiveness of 30%TSC and Heparin Lock Solution in Hemodialysis Catheters Phase 4
Completed NCT01394458 - Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution: A Pilot Study N/A