children, adults, TPN patients, ethanol lock therapy, catheter-related infection and catheter-related thrombosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. TPN patients older than 3 months of age with a tunnelled central venous catheter with a clinical suspicion of a catheter related bloodstream infection 2. Patency of all lumina 3. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Known alcohol allergy 2. Severe clinical sepsis or septic shock 3. Positive culture with a Staf. aureus or Candida species 4. Continuous fluid or TPN dependency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
|---|---|
| - Duration of systemic antibiotic use - Mortality - Adverse reactions of ethanol- or placebo use - Number of days of hospital admission. | — |
Contacts
Academic Medical Center, Amsterdam Emma Children’s Hospital Department of Pediatric Infectious Diseases