N-Acetylcysteine to Prevent Contrast-Induced Nephropathy in Acute Coronary Syndromes
Overview
- Phase
- Phase 4
- Intervention
- intravenous NAC
- Conditions
- Nephropathy
- Sponsor
- Ochsner Health System
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Incidence of CIN
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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. -
Arms & Interventions
intravenous N-acetlycysteine
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.
Intervention: intravenous NAC
Placebo
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of CIN
Time Frame: 48-72 hours
Secondary Outcomes
- in-hospital mortality(30 days)
- 30 day mortality(30 days)
- duration of hospitalization(30 days)
- serum cystatin C(48-72 hours)