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

Ethanol lock solution for the prevention of tunnelled central venous catheter infections in paediatric oncology patients A randomized controlled trial - ethanol lock solution in central lines

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29924

Enrollment

600

Registered

2006-07-04

Start date

2006-09-01

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

prevention of catheter related infection

Interventions

Central randomisation will be performed, allocating the patients to the control or experimental group. Both the patient and the investigators will be blinded to the treatment. The lock solution in th

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Paediatric oncology patients age 1-18 years who will have a central venous tunneled catheter inserted (internal or external device)

Exclusion criteria

Exclusion criteria: all patients who have had a previous catheter inserted patients with signs and symptoms of infection at time of catheter insertion patients

Design outcomes

Primary

Measure	Time 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. Total duration of the study is maximal 6 months. Secondary endpoint: Occurrence of fever (with or without neutropenia), occurrence of thrombosis (clinical or subclinical), antibiotic use, days of hospital admission, clinical severity of the infection, outcome.	—

Measure

Time 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. Total duration of the study is maximal 6 months. Secondary endpoint: Occurrence of fever (with or without neutropenia), occurrence of thrombosis (clinical or subclinical), antibiotic use, days of hospital admission, clinical severity of the infection, outcome.

—

Secondary

Measure	Time frame
Side-effects will be registered, focussing on allergic reactions, "flushing" of the face, dizziness, warm feeling en liver enzyme raise (ASAT. ALAT) these reactions will be registered in the first hour after flushing the lock.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)