N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients
Condition: Radiocontrast Nephropathy
MeSH terms: Kidney Diseases; Emergencies
Intervention: N-Acetylcysteine (NAC); 0.9% Sodium-chloride
Intervention description: Experimental:
Before CT: 3 g NAC IV in 500 cc of 0.9% Sodium-chloride
After CT: 200 mg NAC/hour in 0.9% Sodium-chloride at 67 cc/hour for up to 24 hours.; Placebo:
Before CT: 500 cc 0.9% Sodium-chloride
After CT: NS at 67 cc/hour for up to 24 hours.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive either of two interventions: N-acetylcysteine (Treatment group) or Normal Saline (Placebo group).
Patients in the treatment group will receive 3 g of Nacetylcysteine in 500mL normal saline (0.9% Sodium Chloride) solution during 30 minutes before contrast administration. After contrast administration, patients will receive a continuous infusion of 200mg of N-acetylcysteine per hour, administered as an infusion of 67 mL per hour of a solution of 3 g of N-acetylcysteine diluted to a total volume of 1,000 mL with normal saline solution.
Patients in the placebo group will receive 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration.
Patients in both arms will receive the postcontrast infusion (N-acetylcysteine or saline solution) for a minimum of 2 hours.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The study medication (or placebo) will come premixed from the pharmacy. There will be no external marks on the medication (or placebo) that suggests its identity.
Enrollment: 399.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: NAC; Radiocontrast Nephropathy; N-Acetylcysteine; RCN; RCIN; Creatinine; Computerized Tomography; CT; Emergency Department; ED

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