Phase 2
N=399
N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients
Radiocontrast Nephropathy
Bottom Line
View on ClinicalTrials.gov: NCT00780962 ↗Enrolled (actual)
399
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Number of Participants With Contrast-induced Nephropathy — 14; 12 Participants — p=>0.5
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-Acetylcysteine (NAC) (Drug); 0.9% Sodium-chloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Contrast-induced Nephropathy |
14; 12 | >0.5 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00780962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.