Status:
COMPLETED
Mechanisms of N-acetylcysteine Mediated Vascular Adverse Effects
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
NHS Lothian
Conditions:
Poisoning
Eligibility:
MALE
18-64 years
Phase:
NA
Brief Summary
Paracetamol overdose is the leading cause of acute liver failure in the Western World. N-acetylcysteine (NAC) has been the antidote of choice for over 30 years but its use is associated with adverse e...
Detailed Description
In this study the investigators test the following hypotheses: 1. NAC causes dose-dependent vasodilatation associated with histamine release in vivo. 2. Release of other mediators, known to be associ...
Eligibility Criteria
Inclusion
- Healthy male, non-smoking, volunteers aged between 18-64 years
Exclusion
- Lack of informed consent Age \<18 or \>64 years Current smoker Current involvement in a clinical trial Clinically significant comorbidity: heart failure, hypertension, known hyper-lipidaemia, diabetes mellitus, asthma, coagulopathy or bleeding disorders Current intake of aspirin, other non-steroid anti-inflammatory medications, or vasodilators Recent infective/inflammatory condition Recent blood donation (during the preceding three months)
Key Trial Info
Start Date :
January 3 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01209455
Start Date
January 3 2011
End Date
July 15 2011
Last Update
June 20 2024
Active Locations (1)
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1
Clinical Research Facility, Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SA