Hydrochloric Acid Lock Therapy for Central Line-associated Bloodstream Infections

NCT05376566 | Completed DMC

• 1 other identifier: CHILD@HALT
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 4

Brief Summary

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

Central Line-associated Bloodstream Infection (CLABSI)

Keywords

Central line; Cancer; Lock therapy; Hydrochloric acid; Bloodstream infections; Haematological diseases

Outcome Measures

Primary Outcomes (1)

• Treatment failure.

  Defined as 1) persistent infection (persistent positive blood cultures 24 hours after HALT/placebo) or relapse (a new CLABSI with an identical bacterial isolate), 2) a new CLABSI with any bacterial isolate, 3) infection-related removal of central access device (CVAD), 4) infection-related death. The treatment group comparison will be based on a test of the risk ratio between the two groups.

  Within 6 weeks after HALT or placebo (normal saline) treatment of the CVAD.

Other Outcomes (5)

• Safety outcome 1: Infusion-related reactions i.e. anaphylactic shock, pain, rash or sensory disturbances.

  Within 24 hours after start of HALT or placebo (normal saline) treatment of the CVAD.

• Safety outcome 2: Death or admission to Intensive Care Unit associated to infection

  Within 6 weeks after HALT or placebo (normal saline) treatment of the CVAD.

• Safety outcome 3: Mechanical catheter damage or catheter occlusion requiring thrombolytic therapy.

  Within 6 weeks after HALT or placebo (normal saline) treatment of the CVAD.

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Hydrochloric acid (2 M)

Drug: Hydrochloric Acid (2 M)

Control group

PLACEBO COMPARATOR

Normal saline

Drug: Normal saline

Interventions

Hydrochloric Acid (2 M) DRUG

Hydrochloric acid (2 M) in a volume corresponding to dead space (0.3-1.8 ml) will be instilled and aspirated 10 min later; the instillation is completed 3 times.

Also known as: Intervention

Intervention group

Normal saline DRUG

Normal saline in a volume corresponding to dead space (0.3-1.8 ml) will be instilled and aspirated 10 min later; the instillation is completed 3 times.

Also known as: Placebo

Control group

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Plan to remove CVAD within 6 days.
• Instantly admission to Intensive Care Uni

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (4)

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

Aarhus, 3200, Denmark

Location

Department of Haematology, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Department of Paediatrics and Adolescent Medicine, Odense University Hospital

Odense, 4000, Denmark

Location

Related Publications (3)

• Wolf 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 BACKGROUND

• Larsen 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 BACKGROUND

• Madsen 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 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Sepsis

Interventions

Hydrochloric Acid; Methods; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acids, Noncarboxylic; Acids; Inorganic Chemicals; Chlorine Compounds; Investigative Techniques; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ulrikka Nygaard, MD, ph.d.

  Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be blinded using masked vial containing either hydrochloric acid or normal saline and coloured syringes. All masked vials have a unique three-figure randomization code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Denmark

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)