Nephropathy
Conditions
Keywords
contrast nephropathy, intravenous n-acetlycysteine
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.
Interventions
DRUGintravenous NAC
intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)
DRUGPlacebo
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.
Sponsors
Cumberland Pharmaceuticals
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CIN | 48-72 hours |
Secondary
| Measure | Time frame |
|---|---|
| in-hospital mortality | 30 days |
| 30 day mortality | 30 days |
| duration of hospitalization | 30 days |
| serum cystatin C | 48-72 hours |
Countries
United States
Contacts
Primary ContactArthur Grant, MD
Backup ContactZehra Jaffery, MD
Outcome results
None listed