drugset / Trial / NCT00808795

Efficacy of N-Acetylcysteine in Prevention of Post-Catheterization Contrast-Induced Nephropathy in Diabetic Patients With Chronic Kidney Disease

NCT00808795 ↗

Phase 3 Completed 90 enrolled Tehran University of Medical Sciences
RandomizedParallel-groupQuadruple-blindPrevention

Summary

* Contrast-induced nephropathy (CIN) is the third most common cause of hospital acquired acute kidney injury, accounting for 10% of all cases. * The pathophysiology of CIN is unclear. Possible mechanisms involve 1. Renal tubular injury by oxygen free radicals 2. Reducing renal blood flow which leads to acute tubular necrosis. Since N-acetylcysteine is an antioxidant as well as a vasodilator, it may work in two distinct ways, by preventing reduction in renal blood flow or contrast-induced oxidative damage. * The purpose of this study is to evaluate the efficacy of N-acetylcysteine compared to placebo for the contrast-induced nephropathy prevention.

Timeline

Start
2006-04
Primary completion
2006-10
Completion
2006-10

Outcome

Missed primary endpoint

paper 6 out of 42 (14.3%) patients in the placebo group (P = 0.656). PMID 19563648 ↗

paper There was no detectable benefit for the prophylactic administration of oral NAC over an aggressive hydration protocol in patients with DM and CKD. PMID 19563648 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 600 mg Oral