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

NCT03679442 | Completed Phase 1

• 1 other identifier: PCMsCD163NAC
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Drug-Induced Acute Liver Injury

Keywords

macrophage activation, N-acetylcysteine, acetaminophen

Outcome Measures

Primary Outcomes (2)

• Change from baseline in sCD163

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

  16 hours

• Change from baseline in sCD206

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

  16 hours

Study Arms (1)

Healthy individuals

EXPERIMENTAL

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

Interventions

N-acetylcysteine DRUG

Non-randomized exposure to N-acetylcysteine (NAC) of healthy individuals corresponding to the clinical treatment guidelines for paracetamol-overdosed patients

Also known as: NAC, Paracetamol antidote, Acetylcysteine

Healthy individuals

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75

You may not qualify if:

• A history of previous illness

Sponsors & Collaborators

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

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Henning Grønbæk

  Department of Hepatology and gastroenterology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 20, 2018
• Study Start: September 8, 2014
• Primary Completion: June 14, 2015
• Study Completion: February 18, 2017
• Last Updated: September 24, 2018

Record last verified: 2018-09