Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose
Primary Purpose
Drug-Induced Acute Liver Injury
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
About this trial
This is an interventional basic science trial for Drug-Induced Acute Liver Injury focused on measuring macrophage activation, N-acetylcysteine, acetaminophen
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 75
Exclusion Criteria:
- A history of previous illness
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy individuals
Arm Description
Healthy individuals received intravenous N-acetylcysteine (NAC) treatment to investigate its actions on macrophage activation assessed by the markers soluble CD163 and CD206
Outcomes
Primary Outcome Measures
Change from baseline in sCD163
Change in macrophage activation marker soluble CD163 after treatment of healthy individuals with N-acetylcysteine
Change from baseline in sCD206
Change in macrophage activation marker soluble CD206 after treatment of healthy individuals with N-acetylcysteine
Secondary Outcome Measures
Full Information
NCT ID
NCT03679442
First Posted
September 17, 2018
Last Updated
September 20, 2018
Sponsor
University of Aarhus
Collaborators
The Danish Council for Strategic Research, Novo Nordisk A/S, Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat
1. Study Identification
Unique Protocol Identification Number
NCT03679442
Brief Title
Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose
Official Title
Macrophage Activation, Assessed by Macrophage Markers Soluble CD163 and Soluble CD206, as Indication of Early Liver Cell Damage in Paracetamol Overdose
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 8, 2014 (Actual)
Primary Completion Date
June 14, 2015 (Actual)
Study Completion Date
February 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish Council for Strategic Research, Novo Nordisk A/S, Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Induced Acute Liver Injury
Keywords
macrophage activation, N-acetylcysteine, acetaminophen
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy individuals
Arm Type
Experimental
Arm Description
Healthy individuals received intravenous N-acetylcysteine (NAC) treatment to investigate its actions on macrophage activation assessed by the markers soluble CD163 and CD206
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
NAC, Paracetamol antidote, Acetylcysteine
Intervention Description
Non-randomized exposure to N-acetylcysteine (NAC) of healthy individuals corresponding to the clinical treatment guidelines for paracetamol-overdosed patients
Primary Outcome Measure Information:
Title
Change from baseline in sCD163
Description
Change in macrophage activation marker soluble CD163 after treatment of healthy individuals with N-acetylcysteine
Time Frame
16 hours
Title
Change from baseline in sCD206
Description
Change in macrophage activation marker soluble CD206 after treatment of healthy individuals with N-acetylcysteine
Time Frame
16 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 75
Exclusion Criteria:
A history of previous illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Grønbæk
Organizational Affiliation
Department of Hepatology and gastroenterology, Aarhus University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose
We'll reach out to this number within 24 hrs