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
|Contact: Stephen J Traub, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Stephen J Traub, MD 617-754-2347 email@example.com|
|Principal Investigator:||Stephen J Traub, MD||Beth Israel Deaconess Medical Center, Boston|