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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    Page 1 of 1 (4 locations)

    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