Nephropathy Clinical Trial
Official title:
N-Acetylcysteine to Prevent Contrast-Induced Nephropathy in Acute Coronary Syndromes
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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