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Ethanol Lock in Total parenteral nutrition Infections (ELTI study)

An explorative randomized placebo controlled open-label trial of ethanol lock therapy for the additional treatment of catheter-related bloodstream infections in parenteral nutrition patients with intravascular devices

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23991
Enrollment
50
Registered
2008-06-25
Start date
2008-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

children, adults, TPN patients, ethanol lock therapy, catheter-related infection and catheter-related thrombosis

Interventions

Ethanol lock treatment. The instilled lock needs to dwell for a period of 3 -6 hours. All CRIs will be treated with systemic antimicrobial therapy according to present local bacteriological protoco

Sponsors

AMC
Lead Sponsor

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

MeasureTime 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

MeasureTime frame
- Duration of systemic antibiotic use - Mortality - Adverse reactions of ethanol- or placebo use - Number of days of hospital admission.

Contacts

Public ContactD. Pajkrt

Academic Medical Center, Amsterdam Emma Children’s Hospital Department of Pediatric Infectious Diseases

D.Pajkrt@amc.uva.nl+31 (0)20 5662727

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)