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

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ClinicalTrials.gov Identifier: NCT03679442
Recruitment Status : Completed
First Posted : September 20, 2018
Last Update Posted : September 24, 2018
Sponsor:
Collaborators:
The Danish Council for Strategic Research
Novo Nordisk A/S
Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 17, 2018
First Posted Date  ICMJE September 20, 2018
Last Update Posted Date September 24, 2018
Actual Study Start Date  ICMJE September 8, 2014
Actual Primary Completion Date June 14, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
Macrophage activation markers soluble CD163 and CD206 [ Time Frame: 16 hours ]
Measurement of macrophage activation markers soluble CD163 and CD206 before and after treatment of healthy individuals with N-acetylcysteine
Change History Complete list of historical versions of study NCT03679442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose
Official Title  ICMJE Macrophage Activation, Assessed by Macrophage Markers Soluble CD163 and Soluble CD206, as Indication of Early Liver Cell Damage in Paracetamol Overdose
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Drug-Induced Acute Liver Injury
Intervention  ICMJE Drug: N-acetylcysteine
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
Study Arms  ICMJE Experimental: Healthy individuals
Healthy individuals received intravenous N-acetylcysteine (NAC) treatment to investigate its actions on macrophage activation assessed by the markers soluble CD163 and CD206
Intervention: Drug: N-acetylcysteine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2018)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 18, 2017
Actual Primary Completion Date June 14, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 75

Exclusion Criteria:

  • A history of previous illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03679442
Other Study ID Numbers  ICMJE PCMsCD163NAC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • The Danish Council for Strategic Research
  • Novo Nordisk A/S
  • Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat
Investigators  ICMJE
Principal Investigator: Henning Grønbæk Department of Hepatology and gastroenterology, Aarhus University Hospital
PRS Account University of Aarhus
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP