Ethanol Locks for the Treatment of Central Venous Line Infections
Stopped early · Phase 3
Conditions studied: Bloodstream Infection
In brief
Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections Study Design Randomized Controlled Trial Study Protocol Only those patients meeting all inclusion criteria and no exclusion criteria will be eligible to participate in this study. Once identified, signed informed consent will be obtained from the patient's guardian and the patient himself/herself depending on age. Patients will be randomized into 2 groups: Group 1 - those patients who will receive ethanol lock therapy and Group 2- those patients who will receive placebo therapy in the form of a heparin lock solution. Outcome Measures Treatment success as defined by- * Clearance of the infection as documented by negative blood cultures on day 6 (one day after completed of lock treatment) * Preservation of the line at 30 days post treatment (day 35 of the study), this will be documented by a chart review in CIS and telephone interview to ensure no further growth from blood cultures or infections Treatment failure as defined by- * Clinical worsening during treatment * Removal of the line due to persistent infection or sepsis * Recurrence of infection with the same pathogen within 30 days
Key facts
- Study ID
- NCT00680459
- Run by
- Baystate Medical Center
- People needed
- 13
- Starts
- 2008-05-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2014-03-12
Who can join
Age: 1 and older, up to 23. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age 6 months-23 years
- documented central line infection with bacteria or fungus (positive blood culture)
You may not qualify if…
- allergy or intolerance to ethanol
- pregnant or breastfeeding
- central line tunnel or exit site infection
Where it is running
- Baystate Medical Center — Springfield, Massachusetts, United States
Full record on ClinicalTrials.gov
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