Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy
Status:
Unknown status
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
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.