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

• Conditions: Catheter related bloodstreaminfection; line-infection; 10004018

• Registration Number: NL-OMON33319
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

*Pediatric 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

* 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Treatment failure is defined as occurence of 1 of the following endpoints<br /><br>within<br /><br>24 weeks after start of ethanol/heparin therapy:<br /><br><br /><br>1. Persistent bacteremia >72 hours after start of ethanol/heparin lock OR<br /><br>2. Recurrence of bacteremia (with the same or other micro-organism) within 24<br /><br>weeks OR<br /><br>3. Removal of the CVC OR<br /><br>4. Occurence of symptomatic venous thrombosis </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>Duration of systemic antibiotic use, mortality, adverse reactions of ethanol-<br /><br>or<br /><br>heparin use, number of days of hospital admission. </p><br>