Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Nephropathy
In brief
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.
Key facts
- Study ID
- NCT00939913
- Run by
- Ochsner Health System
- People needed
- 400
- Starts
- 2007-01-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2009-09-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Have end-stage renal disease (ESRD) requiring dialysis.
- Have a known hypersensitivity to NAC.
- Have a history of life-threatening contrast reaction. -
Where it is running
- Ochsner Medical Center — New Orleans, Louisiana, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.