N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients
Information source: Beth Israel Deaconess Medical Center
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Radiocontrast Nephropathy
Intervention: N-Acetycysteine (NAC) (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Beth Israel Deaconess Medical Center Official(s) and/or principal investigator(s):
Stephen J Traub, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center, Boston
Overall contact:
Stephen J Traub, MD, Phone: 617.754.2347, Email: straub@bidmc.harvard.edu
Summary
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:
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.
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.
Clinical Details
Official title: N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Prevention of Radiocontrast Nephropathy, defined by an increase in creatinine of > or = 25% above baseline or an absolute rise of 0.5 mg/dL
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 clincial care
Locations and Contacts
Stephen J Traub, MD, Phone: 617.754.2347, Email: straub@bidmc.harvard.edu
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Stephen J Traub, MD, Phone: 617-754-2347, Email: straub@bidmc.harvard.edu
Additional Information
Starting date: October 2007
Last updated: October 27, 2008
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