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| Sponsored by: |
Tehran University of Medical Sciences |
|---|---|
| Information provided by: | Tehran University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00808795 |
Purpose
The pathophysiology of CIN is unclear. Possible mechanisms involve
| Condition | Intervention | Phase |
|---|---|---|
|
Radiocontrast-Induced Nephropathy Chronic Kidney Disease Diabetes Mellitus |
Drug: N-acetylcysteine Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy of N-Acetylcysteine in Prevention of Contrast-Induced Nephropathy After Cardiac Catheterization in Patients With Diabetes Mellitus and Chronic Kidney Disease: A Randomized Clinical Trial |
| Enrollment: | 90 |
| Study Start Date: | April 2006 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| N-acetylcysteine: Experimental |
Drug: N-acetylcysteine
NAC is to be orally administered at the dose of 600mg twice a day, starting 24h before the procedure (two doses before and two doses after the procedure).
|
| Placebo: Placebo Comparator |
Drug: Placebo
Placebo of NAC is to be orally administered at the dose of 600mg twice a day, starting 24h before the procedure (two doses before and two doses after the procedure).
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Nevertheless, use of radiocontrast media has been associated with increased in-hospital morbidity, mortality, and costs of medical care, long admission, especially in patients needing dialysis. With the increasing use of contrast media in diagnostic and interventional procedures, it has become one of the major challenges encountered during routine cardiovascular practice.
Among them, N-acetylcysteine (NAC) has been of considerable interest. Up to now, several clinical studies and meta-analysis have been performed to assess the efficacy of NAC in prevention of CIN.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have all of the following criteria:
Exclusion Criteria:
Contacts and Locations| Iran, Islamic Republic of | |
| Tehran Heart center | |
| Tehran, Iran, Islamic Republic of, 1411713138 | |
| Study Director: | Manouchehr - Amini, MD | Tehran University of Medical Sciences, Nephrology Department of Dr. Shariati Hospital |
More Information
| Responsible Party: | - ( Tehran University of Medical Sciences, Nephrology Department of Dr. Shariati Hospital ) |
| Study ID Numbers: | 487 |
| Study First Received: | December 13, 2008 |
| Last Updated: | December 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00808795 History of Changes |
| Health Authority: | Iran: Ministry of Health |
|
Acute kidney injury contrast-induced nephropathy Chronic kidney disease Diabetes mellitus N-acetylcysteine |
|
Renal Insufficiency Antioxidants Metabolic Diseases Kidney Failure, Chronic Diabetes Mellitus Endocrine System Diseases Antiviral Agents Urologic Diseases Renal Insufficiency, Chronic |
Expectorants Acetylcysteine Kidney Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder N-monoacetylcystine Kidney Failure |
|
Anti-Infective Agents Respiratory System Agents Renal Insufficiency Antioxidants Metabolic Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Diabetes Mellitus Kidney Failure, Chronic Endocrine System Diseases Protective Agents Antiviral Agents |
Pharmacologic Actions Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Expectorants Free Radical Scavengers Acetylcysteine Kidney Diseases Glucose Metabolism Disorders N-monoacetylcystine Antidotes Kidney Failure |