catheter related bloodstreaminfection line-infection
Conditions
Interventions
Ethanol lock therapy versus placebo lock therapy.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: * total parenteral nutrition patients older than 3 months of age with a tunnelled central venous catheter (see definition below) with a (clinical) suspicion of a Catheter Related bloodstream Infection (CRI) in which according to the treating physician antimicrobial therapy is indicated. All CRIs will simultaneously be treated with systemic antimicrobial agents according to present local guideline. * patency of all lumina prior to initiation of ethanol locks * written informed consent
Exclusion criteria
Exclusion criteria: * known alcohol allergy * severe clinical sepsis or septic shock, defined as the need for vaso-active drugs or mechanical respiratory support * a positive blood culture with a Staphylococcus aureus or Candida species, (the catheter has to be removed in these cases) * continuous fluid or TPN dependency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure is defined as occurence of 1 of the following endpoints within 24 weeks after start of ethanol/placebo therapy: 1. Persistent bacteremia >72 hours after start of ethanol/placebo lock OR 2. Recurrence of bacteremia (with the same or other micro-organism) within 24 weeks OR 3. Removal of the CVC OR 4. Occurence of symptomatic venous thrombosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Duration of systemic antibiotic use, mortality, adverse reactions of ethanol- or placebo use, number of days of hospital admission. | — |
Countries
Netherlands
Outcome results
None listed