Central Line-associated Bloodstream Infection (CLABSI)
Conditions
Keywords
Central Line-associated Bloodstream Infection, Paediatric oncology patients, Central venous access device
Brief summary
The goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.
Interventions
DEVICETauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
DEVICEHeparin lock (heparin 100 IU/mL)
The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
Sponsors
Dutch Cancer Society
UMC Utrecht
Princess Maxima Center for Pediatric Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age between 0 - \<19 years * Radiological, cytological or histological proven paediatric malignancy (hematologic, solid, and neurologic malignancies) * Tunnelled external central venous access device or totally implantable venous access port to be inserted at the Princess Máxima Center for Pediatric Oncology * Planned central venous access device insertion of \>90 days * Written consent signed according to local law and regulations * Parents/guardians or patient are willing and able to comply with the trial procedure
Exclusion criteria
* A previous central venous access device removed \< 12 months ago. * Expected treatment for a majority of the follow-up time in a different hospital than the Princess Maxima Center for pediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the Princess Maxima Center at least once every 3 weeks. * Primary immunological disorder * Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia. * Documented bacteremia in the period from 24h before catheter insertion until inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of central line associated bloodstream infections | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
Secondary
| Measure | Time frame |
|---|---|
| Central line associated bloodstream infection incidence per 1,000 central venous access device-days | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Incidence of symptomatic central venous thrombosis | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Incidence of bacteraemia | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Incidence of local infections | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Time to first central line associated bloodstream infection | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Incidence of and reasons for central venous access device-removal | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Cultured microorganisms causing central line associated bloodstream infections | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Safety in terms of known side effects, severe adverse events, intensive care unit admission, and mortality rate due to central line associated bloodstream infections/central venous thrombosis | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
Countries
Netherlands
Contacts
Primary ContactCeder H van den Bosch, MSc
Outcome results
None listed