Ethanol lock solution for the prevention of tunnelled central venous catheter infections in paediatric oncology patients A randomized controlled trial
Phase 3
- Conditions
- prevention of catheter related infection10019815
- Registration Number
- NL-OMON29924
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
Paediatric oncology patients age 1-18 years
who will have a central venous tunneled catheter inserted (internal or external device)
Exclusion Criteria
all patients who have had a previous catheter inserted
patients with signs and symptoms of infection at time of catheter insertion
patients<1 year of age
patients with an allergy for alcohol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>First Endpoint : All patients will be prospectively followed till time of first<br /><br>documented catheter related infection, till death, or till removal of the<br /><br>catheter, whatever endpoint will come first. Total duration of the study is<br /><br>maximal 6 months.<br /><br>Secondary endpoint: Occurrence of fever (with or without neutropenia),<br /><br>occurrence of thrombosis (clinical or subclinical), antibiotic use, days of<br /><br>hospital admission, clinical severity of the infection, outcome.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Side-effects will be registered, focussing on allergic reactions, flushing of<br /><br>the face, dizziness, warm feeling en liver enzyme raise (ASAT. ALAT)<br /><br>these reactions will be registered in the first hour after flushing the lock.</p><br>