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Phase 2 N=399 Randomized Quadruple-blind Prevention

N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients

Radiocontrast Nephropathy

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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