N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients

• Status: Completed
• Trial end date: 2010-08-09
• Target enrollment: 0
• Participant gender: All

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 nephropathy have been promising. However, previous studies have limited applicability to the Emergency Department (ED) patient population for two reasons:

• 1) Many of the pretreatment strategies employed in these studies take several hours or even days to perform, which is not feasible in acutely ill ED patients.

• 2) Most of these studies were conducted in patients undergoing cardiac catheterization. This may be a very different population than patients in the ED undergoing abdominal or chest computed tomography.

The investigators wish to study the efficacy of N-acetylcysteine as an agent to prevent radiocontrast nephropathy in ED patients undergoing computerized tomography. The investigators propose a randomized, double-blind, controlled trial comparing saline hydration plus N-acetylcysteine versus saline hydration alone. The hypothesis of this study is that N-acetylcysteine with normal saline will be more effective than saline alone in the prevention of radiocontrast nephropathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Cumberland Pharmaceuticals
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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