Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material
Radiocontrast-induced Nephropathy
About this trial
This is an interventional prevention trial for Radiocontrast-induced Nephropathy focused on measuring contrast nephropathy, radiocontrast-induced nephropathy, chronic kidney disease, acetylcysteine, clinical study
Eligibility Criteria
Inclusion Criteria:
- Study 1 and 3: Healthy male volunteers over 45 years of age with BMI between 22 and 40.
- Study 2: Male volunteers with CKD III with BMI between 22 and 40.
- Study 4: Male patients over 45 year of age with stable CKD III and BMI between 22 and 40, undergoing elective coronary angiography.
Exclusion Criteria for studies 1 and 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, peripheral vascular disease, 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, in particular beta blockers
- recent infective/inflammatory condition
- blood donation during the preceding three months
Exclusion criteria for studies 2 and 4:
- 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
- Recent infective/inflammatory condition
- Blood donation during the preceding three months
Sites / Locations
- Clinical Research Facility, Royal Infirmary Edinburgh
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
1
2
3
4
Healthy volunteers will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Volunteers with CKD III will be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Healthy volunteers will receive a single IV dose of 100mls Visipaque 320 (iodixanol, equivalent to 320 mg iodine/ml). They will then be randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline
Volunteers with CKD III will receive Visipaque 320 during coronary angiography. They will have been randomised to receive either placebo capsules PO plus an infusion of normal saline, acetylcysteine capsules PO plus an infusion of normal saline or placebo capsules PO plus an IV infusion of acetylcysteine in normal saline