Clinical trial · Interventional
Hydrochloric Acid Lock Therapy for Central Line-associated Bloodstream Infections
Hydrochloric Acid Lock Therapy for Central Line-associated Bloodstream Infections in Patients With Cancer and Hematologic Diseases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aim: This study will test whether treatment of central line-associated bloodstream infections (CLABSI) with hydrochloric acid lock therapy (HALT) can significantly reduce the risk of treatment failure (comprising failure to clear initial infection, relapse of infection, or reinfection) in patients treated for cancer or hematologic diseases. Study design: A multicentre, double-blinded, randomized controlled trial. Patient population: Patients (0-100 y) with cancer or a hematologic disorder and a CLABSI treated at Copenhagen University Hospital, Aarhus University Hospital, or Odense University Hospital, Denmark. Randomization: Patients are equally assigned (1:1) to receive either HALT or placebo (normal saline). In addition to the study intervention, patients in both arms will receive standard systemic antibiotic therapy. Sample size: A target population of 250 patients Statistical Analysis Plan is uploaded in "Study Documents"
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Line-associated Bloodstream Infection (CLABSI) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrochloric Acid (2 M) | Drug | — | UNRESOLVED |
| Normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention group
- description
- Hydrochloric acid (2 M)
- interventionNames
- Drug: Hydrochloric Acid (2 M)
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Normal saline
- interventionNames
- Drug: Normal saline
Primary outcomes (1)
- measure
- Treatment failure.
- timeFrame
- Within 6 weeks after HALT or placebo (normal saline) treatment of the CVAD.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion criteria * Patients aged 0-17 years treated at pediatric oncologic department at Copenhagen University Hospital, Odense University Hospital, and Aarhus University Hospital, Denmark. Inclusion of children and adolescents from 1st of June 2022. * Patients aged 18-100 years treated at Department of Hematology, Copenhagen University Hospital, Denmark. Inclusion of adult patients from 17th of October 2023. * Patients receiving treatment for cancer or a hematologic disease (any type and at any point in the course of the disease). * CVAD in situ (intravenous ports and all central lines). * New diagnosis of CLABSI (defined as a laboratory-confirmed bloodstream infection, not secondary to infection at another site, in a patient who has a CVAD). NB, patients who had a CLABSI prior to the beginning of the study are accepted for enrollment if they have a new CLABSI during the patient enrollment phase. The patient is followed 6 weeks from instillation with HALT/placebo. The patient can be re-included if the patient has 1) replacement of the CVAD, or 2) a new CLABSI later than 6 weeks from a previous CLABSI. In case of re-inclusion the patient, the patient will be randomized again. Exclusion Criteria: * Plan to remove CVAD within 6 days. * Instantly admission to Intensive Care Uni
References
Publications (3)
- BACKGROUNDWolf J, Connell TG, Allison KJ, Tang L, Richardson J, Branum K, Borello E, Rubnitz JE, Gaur AH, Hakim H, Su Y, Federico SM, Mechinaud F, Hayden RT, Monagle P, Worth LJ, Curtis N, Flynn PM. Treatment and secondary prophylaxis with ethanol lock therapy for central line-associated bloodstream infection in paediatric cancer: a randomised, double-blind, controlled trial. Lancet Infect Dis. 2018 Aug;18(8):854-863. doi: 10.1016/S1473-3099(18)30224-X. Epub 2018 Jun 5. PMID 29884572
- BACKGROUNDLarsen LN, Malchau E, Kristensen B, Schroeder H. Hydrochloric acid treatment of tunneled central venous catheter infections in children with cancer. J Pediatr Hematol Oncol. 2011 Mar;33(2):e64-8. doi: 10.1097/MPH.0b013e3181f6933d. PMID 21285898
- BACKGROUNDMadsen M, Rosthoj S. Impact of hydrochloric acid instillation on salvage of infected central venous catheters in children with acute lymphoblastic leukaemia. Scand J Infect Dis. 2013 Jan;45(1):38-44. doi: 10.3109/00365548.2012.708941. Epub 2012 Sep 19. PMID 22992112