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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
Inclusion Criteria

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

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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