Ethanol Locks for the Treatment of Central Venous Line Infections
Status:
Terminated
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
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