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Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT03679442
Collaborator
The Danish Council for Strategic Research (Other), Novo Nordisk A/S (Industry), Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat (Other)
16
Enrollment
1
Arm
29.4
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Paracetamol (PCM) is a widely used over-the-counter analgesic, and overdose with PCM is a condition regularly seen in everyday clinical practice. Identification of the patients with early signs of liver injury that may develop into acute liver failure is important. Previous research has shown that macrophages play a role in the development of liver damage in PCM-induced acute liver failure, making macrophage markers interesting possible biomarkers of this condition. In the present study, the investigators aimed to investigate the extent and timing of macrophage activation in PCM-induced liver injury by measuring levels of macrophage markers sCD163 and sCD206 in patients admitted with PCM overdose. The investigators also hoped to find out whether these markers are valuable as prognostic markers of severe outcome in these patients.

Furthermore the investigators examined the possible effect of antidote treatment with N-acetylcysteine on activation and function of macrophages by administering NAC to healthy subjects and measuring levels of sCD163 and sCD206 prior to and after completion of treatment.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The part of the study concerning the patients with PCM overdose was strictly observational with measurement of macrophage markers and no other intervention than the NAC treatment administered in the setting of management of the participants PCM overdose according to best clinical practice.

The interventional part of the study which is submitted for registration here concerns only healthy controls who were exposed to NAC treatment in order to assess the direct effects of NAC on macrophages. The participants received NAC treatment according to the same protocol as the PCM overdosed patients, and macrophage activation markers were measured prior to and after 16 hours of NAC treatment. Thus, the involvement of the participants in the study was limited to the 16 hours of NAC treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Macrophage Activation, Assessed by Macrophage Markers Soluble CD163 and Soluble CD206, as Indication of Early Liver Cell Damage in Paracetamol Overdose
Actual Study Start Date :
Sep 8, 2014
Actual Primary Completion Date :
Jun 14, 2015
Actual Study Completion Date :
Feb 18, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy individuals

Healthy individuals received intravenous N-acetylcysteine (NAC) treatment to investigate its actions on macrophage activation assessed by the markers soluble CD163 and CD206

Drug: N-acetylcysteine
Non-randomized exposure to N-acetylcysteine (NAC) of healthy individuals corresponding to the clinical treatment guidelines for paracetamol-overdosed patients
Other Names:
  • NAC
  • Paracetamol antidote
  • Acetylcysteine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in sCD163 [16 hours]

      Change in macrophage activation marker soluble CD163 after treatment of healthy individuals with N-acetylcysteine

    2. Change from baseline in sCD206 [16 hours]

      Change in macrophage activation marker soluble CD206 after treatment of healthy individuals with N-acetylcysteine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 18 to 75
    Exclusion Criteria:
    • A history of previous illness

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Aarhus
    • The Danish Council for Strategic Research
    • Novo Nordisk A/S
    • Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat

    Investigators

    • Principal Investigator: Henning Grønbæk, Department of Hepatology and gastroenterology, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT03679442
    Other Study ID Numbers:
    • PCMsCD163NAC
    First Posted:
    Sep 20, 2018
    Last Update Posted:
    Sep 24, 2018
    Last Verified:
    Sep 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Aarhus
    macrophage activation, N-acetylcysteine, acetaminophen
    Additional relevant MeSH terms:
    Chemical and Drug Induced Liver Injury
    Acetylcysteine
    N-monoacetylcystine
    Antidotes

    Study Results

    No Results Posted as of Sep 24, 2018