Status:
COMPLETED
N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Cumberland Pharmaceuticals
Conditions:
Radiocontrast Nephropathy
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
Multiple agents have been studied to prevent radiocontrast nephropathy. One of these agents is N-Acetylcysteine. Previous trials to assess N-Acetylcysteine's efficacy in the prevention of contrast nep...
Detailed Description
Out of the approximately 110 million Emergency Department (ED) visits in the United States each year approximately 8.8 million people undergo Contrast-Enhanced Computerized Tomography (CT) studies in ...
Eligibility Criteria
Inclusion
- Undergoing a CT with intravenous contrast as part of clinical care
- 18 years of age or older
- Willingness to have a serum creatinine measured 48-72 hours after study
- Presence of one or more risk factors for radiocontrast nephropathy:
- Creatinine greater than or equal to 1.4 mg/dL
- Estimated Glomerular Filtration Rate (eGFR) of less than 60 mL/min/1.73m2
- Diabetes Mellitus
- Hypertension being treated with anti-hypertensive mediations
- Coronary artery disease
- Concurrent use of any of the following nephrotoxic drugs:
- Cyclosporine A
- Aminoglycosides
- Amphotericin
- Cisplatin
- Non-steroidal anti-inflammatory drugs
- Congestive heart failure (active or by history)
- Older age (65 years of age or older)
- Anemia (hematocrit \< 30%)
Exclusion
- Unable or unwilling to provide informed consent
- End-stage renal disease currently undergoing regular hemodialysis
- Pregnant
- Known allergy to N-acetylcysteine
- Too unstable to wait for infusion of medication or placebo
- Treating physician using N-Acetylcysteine as part of clinical care
Key Trial Info
Start Date :
October 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2010
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT00780962
Start Date
October 16 2007
End Date
August 9 2010
Last Update
October 29 2024
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215