Ethanol Locks for the Treatment of Central Venous Line Infections
Condition: Bloodstream Infection
MeSH terms: Infections; Communicable Diseases; Sepsis
Intervention: 70% ethanol; heparin flush solution
Intervention description: 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.; heparin flush (10 units/ml) lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. Heparin lock solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Intervention MeSH terms: Ethanol; Heparin; Anticoagulants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 13.0
Sex: All
Minimum age: 6 Months
Maximum age: 23 Years
Healthy volunteers: No
Keywords: central line infection; 70% ethanol; Sepsis

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
    

Eligibility 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