N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients
Recruitment status was: Recruiting
Multiple agents have been studied to prevent radiocontrast nephropathy after the administration of radiocontrast agents. One of these agents is N-acetylcysteine. Previous trials to assess the efficacy of n-acetylcystenine in the prevention of contrast nephropathy have been promising.
Previous work in this field has limited applicability to the Emergency Department (ED) patient population for two reasons:
- 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.
- 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.
We wish to study the efficacy of N-acetylcysteine as an agent to prevent radiocontrast nephropathy in ED patients undergoing computerized tomography. We 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients|
- Prevention of Radiocontrast Nephropathy, defined by an increase in creatinine of > or = 25% above baseline or an absolute rise of 0.5 mg/dL [ Time Frame: 48-96 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Drug: N-Acetycysteine (NAC)
Experimental: 3 g NAC IV in 500 cc Normal Saline (NS) before CT, followed by 200 mg NAC/hour in NS at 67 cc/hour for up to 24 hours after CT.
Placebo: 500 cc NS before CT, followed by NS at 67 cc/hour after CT
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780962
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Stephen J Traub, MD||Beth Israel Deaconess Medical Center, Boston|