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

NCT03679442 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-09-24

No results posted yet for this study

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

Interventions

DRUG

N-acetylcysteine

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

Sponsors & Collaborators

  • The Danish Council for Strategic Research

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat

    collaborator UNKNOWN

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Henning Grønbæk · Department of Hepatology and gastroenterology, Aarhus University Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-08
Primary Completion
2015-06-14
Completion
2017-02-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03679442 on ClinicalTrials.gov