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The Aristocaths study

Ethanol lock solution for the prevention of tunnelled central venous catheter infections in paediatric oncology patients, a randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22330
Enrollment
600
Registered
2008-04-14
Start date
2007-10-01
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

aristocaths, catheter infections, catheter infecties, Ethanol lock solution, paediatric oncology patients

Interventions

Central randomisation will be performed, allocating the patients to the control or experimental group. Both the patient and the investigators will be blinded tot the treatment. The experimental grou

Sponsors

Academic Medical Center, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Children who have a documented infection at the time of catheter insertion 2. Children <1 year at diagnosis 3. Children with an existing primary immunological disorder 4. Placement of the central venous catheter in the site of a previously radiographically confirmed venous thrombosis 5. Allergy for ethanol

Design outcomes

Primary

MeasureTime frame
First endpoint: 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. Secondary endpoint: Occurence of fever (with or without neutropenia), occurence of thrombosis (clinical or subclinical days of hospital admission, clinical sverity of the infection, outcome.

Secondary

MeasureTime frame
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.

Contacts

Public ContactK.M. Pal, van der-de Bruin

TNO Quality of Life, P.O. Box 2215

KM.vanderPal@pg.tno.nl+31 (0)71 5181836

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)