CompletedPhase 3

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

Iran90 participantsStarted 2006-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients who have all of the following criteria: * Aged older than 18 years old * A history of diabetes mellitus for at least one year * chronic kidney disease, defined as serum creatinine concentration \>=1.5mg/dL for men and \>=1.4mg/dL for women. Exclusion Criteria: * Acute coronary syndrome requiring primary or rescue coronary intervention within less than 12h * Cardiogenic shock * Current peritoneal or hemo-dialysis * A known allergy to NAC

What they're measuring

Incidence of CIN, defined as increase in serum creatinine concentration>=0.5mg/dL(44.2micromol/L) or >=25% above baseline.

Timeframe: 48 hours after exposure to contrast medium

Trial details

NCT IDNCT00808795

SponsorTehran University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-10

View on ClinicalTrials.gov More Radiocontrast-Induced Nephropathy trials