Hydrochloric acid therapy for central line-associated bloodstream infection in children with cancer

This trial is evaluating the effect of hydrochloric acid lock therapy in children with cancer and central line-associated bloodstream infections.

​A research project by Mette Bondo Mønster

Background

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.

Hypothesis

HALT reduces treatment failure of CLABSI by more than 50%, without adverse events. 

Methods

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. 

Perspectives

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.
 


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