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
- Conditions
- Radiocontrast-induced nephropathy
- Registration Number
- EUCTR2006-003509-18-GB
- Lead Sponsor
- niversity of Edinburgh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Studies 1 & 3:
Healthy male volunteers aged over 45 years, with a BMI between 22 and 40.
Study 2:
Male volunteers aged over 45 years, with stable CKD stage III and a BMI between 22 and 40, not on metformin.
Study 4:
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.
Study 5:
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method