Ethanol in the Prevention of Central Venous Catheter Infections
Primary Purpose
Catheter Related Infection
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ethanol
Heparine
Sponsored by
About this trial
This is an interventional prevention trial for Catheter Related Infection focused on measuring infection, catheter, bacteriaemia, ethanol
Eligibility Criteria
Inclusion Criteria:
- older than 18 years old
- Signed informed consent
- central Venous catheter more than 48 hours placed
Exclusion Criteria:
- pregnancy
- denial Informed consent Form
- ethanol intolerance
- Liver cirrhosis
Sites / Locations
- Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ethanol
Heparine
Arm Description
Every three day lock using Ethanol in all the lumen of the Catheter
Every three day lock using Heparine in all the lumen of the Catheter
Outcomes
Primary Outcome Measures
catheter infectionrelated incidence rates
decrease on catheter infection related incidence rates in comparison to the institution incidence figures
Secondary Outcome Measures
cathether bacteriaemia related rate
versus Institution rate figures
antimicrobial consume
Defined Diary Dosis(DDDs)in both arms
Full Information
NCT ID
NCT01229592
First Posted
October 18, 2010
Last Updated
July 16, 2012
Sponsor
Hospital General Universitario Gregorio Marañon
1. Study Identification
Unique Protocol Identification Number
NCT01229592
Brief Title
Ethanol in the Prevention of Central Venous Catheter Infections
Official Title
Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General Universitario Gregorio Marañon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Related Infection
Keywords
infection, catheter, bacteriaemia, ethanol
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ethanol
Arm Type
Experimental
Arm Description
Every three day lock using Ethanol in all the lumen of the Catheter
Arm Title
Heparine
Arm Type
Active Comparator
Arm Description
Every three day lock using Heparine in all the lumen of the Catheter
Intervention Type
Drug
Intervention Name(s)
Ethanol
Intervention Description
Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter
Intervention Type
Drug
Intervention Name(s)
Heparine
Intervention Description
Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter
Primary Outcome Measure Information:
Title
catheter infectionrelated incidence rates
Description
decrease on catheter infection related incidence rates in comparison to the institution incidence figures
Time Frame
2 years
Secondary Outcome Measure Information:
Title
cathether bacteriaemia related rate
Description
versus Institution rate figures
Time Frame
2 years
Title
antimicrobial consume
Description
Defined Diary Dosis(DDDs)in both arms
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
older than 18 years old
Signed informed consent
central Venous catheter more than 48 hours placed
Exclusion Criteria:
pregnancy
denial Informed consent Form
ethanol intolerance
Liver cirrhosis
Facility Information:
Facility Name
Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24675993
Citation
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.
Results Reference
derived
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Ethanol in the Prevention of Central Venous Catheter Infections
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