The Aristocaths study
Recruiting
- Conditions
- aristocaths, catheter infections, catheter infecties, Ethanol lock solution, paediatric oncology patients
- Registration Number
- NL-OMON22330
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
Paediatric oncology patients between 1 and 18 years of age with a newly inserted tunnelled central venous catheter (both internal and external devices) will be eligible for the study.
Exclusion Criteria
1. Children who have a documented infection at the time of catheter insertion
2. Children <1 year at diagnosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method First endpoint: <br /><br>All patients will be prospectively followed till time of first documented catheter related infection, till death, or till removal of the catheter, whatever endpoint will come first. Maximum duration of the study 6 months.<br /><br><br>Secondary endpoint:<br /><br>Occurence of fever (with or without neutropenia), occurence of thrombosis (clinical or subclinical days of hospital admission, clinical sverity of the infection, outcome.<br>
- Secondary Outcome Measures
Name Time Method Side effects will be registered, focussing on allergic reactions, flushing” of the face, dizziness, warm feeling and liver (ASAT, ALAT) These reactions will be registered in the first hour after flushing the lock.