Ethanol in the Prevention of Central Venous Catheter Infections
NCT ID: NCT01229592
Last Updated: 2012-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
200 participants
INTERVENTIONAL
2009-12-31
2012-02-29
Brief Summary
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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 Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Ethanol
Every three day lock using Ethanol in all the lumen of the Catheter
Ethanol
Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter
Heparine
Every three day lock using Heparine in all the lumen of the Catheter
Heparine
Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter
Interventions
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Ethanol
Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter
Heparine
Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* central Venous catheter more than 48 hours placed
Exclusion Criteria
* denial Informed consent Form
* ethanol intolerance
* Liver cirrhosis
18 Years
ALL
No
Sponsors
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Hospital General Universitario Gregorio Marañon
OTHER
Responsible Party
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Locations
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Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon
Madrid, Madrid, Spain
Countries
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References
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Perez-Granda MJ, Barrio JM, Munoz P, Hortal J, Rincon C, Rabadan PM, Pernia MS, Bouza E. Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial. PLoS One. 2014 Mar 27;9(3):e91838. doi: 10.1371/journal.pone.0091838. eCollection 2014.
Other Identifiers
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2007-007063-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EC07/90653
Identifier Type: -
Identifier Source: org_study_id