Drug-Induced Acute Liver Injury Clinical Trial
Official title:
Macrophage Activation, Assessed by Macrophage Markers Soluble CD163 and Soluble CD206, as Indication of Early Liver Cell Damage in Paracetamol Overdose
Verified date | September 2018 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | February 18, 2017 |
Est. primary completion date | June 14, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age 18 to 75 Exclusion Criteria: - A history of previous illness |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Novo Nordisk A/S, Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat, The Danish Council for Strategic Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in sCD163 | Change in macrophage activation marker soluble CD163 after treatment of healthy individuals with N-acetylcysteine | 16 hours | |
Primary | Change from baseline in sCD206 | Change in macrophage activation marker soluble CD206 after treatment of healthy individuals with N-acetylcysteine | 16 hours |
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