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

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.

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Key information

Conditions

Drug-Induced Acute Liver Injury Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Liver Diseases Poisoning

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 to 75

Exclusion criteria

A history of previous illness

Treatment and study plan

N-acetylcysteine

Drug

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

Primary outcomes

Change from baseline in sCD163

Time frame: 16 hours

Change in macrophage activation marker soluble CD163 after treatment of healthy individuals with N-acetylcysteine
Change from baseline in sCD206

Time frame: 16 hours

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study title

Macrophage Activation, Assessed by Macrophage Markers Soluble CD163 and Soluble CD206, as Indication of Early Liver Cell Damage in Paracetamol Overdose

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2017
First posted: Sep 20, 2018
Registry last updated: Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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