A research project by Mette Bondo Mønster
Central line-associated bloodstream infections (CLABSI) are a major threat to children with cancer. Hydrochloric acid lock therapy (HALT) is routinely used in children with CLABSI in Denmark to prevent treatment failure, but no high-quality evidence exists. The aim of this nationwide, randomized trial is to evaluate the effect HALT.
HALT reduces treatment failure of CLABSI by more than 50%, without adverse events.
Study design: A nationwide, randomized trial to investigate if HALT is superior to no lock therapy of the central line in children with cancer and CLABSI.
Patient population: Patients aged 0-18 years from the Danish pediatric oncology centers.
Randomization: 1:1 assignment of HALT or no lock therapy during the first 72 hours of CLABSI.
Primary endpoint: Treatment failure; defined as persistent or recurrent bacteremia within 12 weeks after HALT or no lock therapy.
Secondary endpoints: 1) CLABSI attributable catheter removal, 2) death or admission to Pediatric Intensive Care Unit associated to CLABSI, 3) mechanical catheter damage, 4) reinfection with a different pathogen within 12 weeks after HALT or no lock therapy 5) infusion related reactions.
Sample size: A total of 160 CLABSI.
Inclusion period: 24 months.
This study will be the first randomized trial worldwide investigating the impact of hydrochloric acid as catheter lock therapy. It will be an important contribution to treatment guidelines for CLABSI.