Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2007 |
| End Date: | May 2010 |
| Contact: | Arthur Grant, MD |
| Email: | agrant@ochsner.org |
| Phone: | (504) 842-6281 |
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.
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.
Inclusion Criteria:
1. 18 years of age or older.
2. Hospitalized with a primary diagnosis of acute coronary syndrome.
3. Scheduled for coronary angiography or intervention during the current
hospitalization.
Exclusion Criteria:
1. Have end-stage renal disease (ESRD) requiring dialysis.
2. Have a known hypersensitivity to NAC.
3. Have a history of life-threatening contrast reaction. -
We found this trial at
1
site
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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