Study Stopped
The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations
Ethanol in the Prevention of Central Venous Catheter Infections
Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections
2 other identifiers
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJuly 17, 2012
July 1, 2012
2.2 years
October 18, 2010
July 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
catheter infectionrelated incidence rates
decrease on catheter infection related incidence rates in comparison to the institution incidence figures
2 years
Secondary Outcomes (2)
cathether bacteriaemia related rate
2 years
antimicrobial consume
2 years
Study Arms (2)
Ethanol
EXPERIMENTALEvery three day lock using Ethanol in all the lumen of the Catheter
Heparine
ACTIVE COMPARATOREvery three day lock using Heparine in all the lumen of the Catheter
Interventions
Eligibility Criteria
You may qualify if:
- older than 18 years old
- Signed informed consent
- central Venous catheter more than 48 hours placed
You may not qualify if:
- pregnancy
- denial Informed consent Form
- ethanol intolerance
- Liver cirrhosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon
Madrid, Madrid, 28007, Spain
Related Publications (1)
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.
PMID: 24675993DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 28, 2010
Study Start
December 1, 2009
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
July 17, 2012
Record last verified: 2012-07