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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01229592
Enrollment
200
Registered
2010-10-28
Start date
2009-12-31
Completion date
2012-02-29
Last updated
2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Related Infection

Keywords

infection, catheter, bacteriaemia, ethanol

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).

Interventions

DRUGEthanol

Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter

Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter

Sponsors

Hospital General Universitario Gregorio Marañon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
catheter infectionrelated incidence rates2 yearsdecrease on catheter infection related incidence rates in comparison to the institution incidence figures

Secondary

MeasureTime frameDescription
cathether bacteriaemia related rate2 yearsversus Institution rate figures
antimicrobial consume2 yearsDefined Diary Dosis(DDDs)in both arms

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026