Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy

Study Overview
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Brief Summary
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In patients undergoing coronary angiography, the incidence of contrast induced nephropathy(CIN)varies widely and ranges from < 5% in the lowest risk patients, to nearly 50% in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic administration of intravenous NAC. This is a prospective, randomized, double-blind, placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc (www.cumberlandpharma.com). Patients will be excluded if they have end-stage renal disease requiring dialysis,known hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration of hospitalization and change in serum cystatin C level.

Official Title
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N-Acetylcysteine to Prevent Contrast-Induced Nephropathy in Acute Coronary Syndromes

Conditions
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Nephropathy

Intervention / Treatment
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* Drug: intravenous NAC
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Hospitalized with a primary diagnosis of acute coronary syndrome. Scheduled for coronary angiography or intervention during the current hospitalization. Exclusion Criteria: Have end-stage renal disease (ESRD) requiring dialysis. Have a known hypersensitivity to NAC. Have a history of life-threatening contrast reaction. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: intravenous N-acetlycysteine<br>intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)as compared to placebo Acetadote provided by Cumberland Pharmaceuticals Inc. | Drug: intravenous NAC<br>* intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)<br>|
| Placebo Comparator: Placebo<br>Study participants will be randomized to receive an intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours) or placebo. | Drug: Placebo<br>* Study participants will be randomized to receive an intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours) or placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CIN |  | 48-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital mortality |  | 30 days | 
| 30 day mortality |  | 30 days | 
| duration of hospitalization |  | 30 days | 
| serum cystatin C |  | 48-72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast nephropathy, intravenous n-acetlycysteine