EUCTR2006-003509-18-GBActive, not recruitingNot Applicable
Mechanisms for the effect of acetylcysteine on renal function after exposure to radiographic contrast material - Effect of acetylcysteine on renal function after exposure to contrast
niversity of Edinburgh0 sitesStarted: June 14, 2007Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •Studies 1 & 3:
- •Healthy male volunteers aged over 45 years, with a BMI between 22 and 40.
- •Male volunteers aged over 45 years, with stable CKD stage III and a BMI between 22 and 40, not on metformin.
- •Male patients aged over 45 years, with stable CKD stage III and a BMI between 22 and 40, not on metformin, undergoing elective coronary angiography.
- •Male patients aged over 45 years, with stable CKD stage III and a BMI between 22 and 40, not on metformin, undergoing elective CT.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Volunteers for Studies 1, 3
- •· lack of informed consent
- •· age <46 years
- •· current involvement in a clinical trial
- •· clinically significant co-morbidity: heart failure, hypertension, known
- •hyperlipidaemia, diabetes mellitus, coagulopathy or bleeding disorder.
- •· thyroid disease, myasthenia gravis, asthma, atopy, or a history of
- •allergy/sensitivity to acetylcysteine or contrast medium
- •· current intake of prescription medicines
- •· recent infective/inflammatory condition
- •· blood donation during the preceding three months
- •Patients for Studies 2, 4 and 5
- •· lack of informed consent
- •· age <46 years
- •· current involvement in a clinical trial
- •· thyroid disease, myasthenia gravis, asthma, atopy, or a history of
- •allergy/sensitivity to acetylcysteine or contrast medium
- •· current intake of metformin
- •· recent infective/inflammatory condition
- •· blood donation during the preceding three months
Investigators
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