Ethanol Locks for the Treatment of Central Venous Line Infections

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baystate Medical Center
• Treatments: Anti-Infective Agents; Anticoagulants; Calcium heparin; Ethanol; Heparin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• age 6 months-23 years

• documented central line infection with bacteria or fungus (positive blood culture)

Exclusion Criteria:

• allergy or intolerance to ethanol

• pregnant or breastfeeding

• central line tunnel or exit site infection