Status:
RECRUITING
Hydrochloric Acid Lock Therapy for Central Line-associated Bloodstream Infections
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Odense University Hospital
Aarhus University Hospital
Conditions:
Central Line-associated Bloodstream Infection (CLABSI)
Eligibility:
All Genders
Up to 100 years
Phase:
NA
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...
Detailed Description
BACKGROUND Patients with cancer or hematologic diseases and a long-term central venous access device (CVAD), including central venous catheters and intravenous ports, are at risk of developing centra...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05376566
Start Date
June 1 2022
End Date
June 15 2026
Last Update
September 5 2025
Active Locations (4)
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1
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus, Denmark, 3200
2
Department of Haematology, Copenhagen University Hospital
Copenhagen, Denmark, 2100
3
Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital
Copenhagen, Denmark, 2100
4
Department of Paediatrics and Adolescent Medicine, Odense University Hospital
Odense, Denmark, 4000