Clinical trial NCT03679442: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-Induced Acute Liver Injury
Keywords: macrophage activation, N-acetylcysteine, acetaminophen
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Council for Strategic Research
name: Novo Nordisk A/S
name: Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat
First posted: 2018-09-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 75

Exclusion Criteria:

* A history of previous illness

Primary outcomes:
measure: Change from baseline in sCD163
timeFrame: 16 hours
measure: Change from baseline in sCD206
timeFrame: 16 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Hepatology and gastroenterology, Aarhus University Hospital
name: Henning Grønbæk
role: PRINCIPAL_INVESTIGATOR
References: