We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00780962
Recruitment Status : Unknown
Verified October 2008 by Beth Israel Deaconess Medical Center.
Recruitment status was:  Recruiting
First Posted : October 28, 2008
Last Update Posted : October 28, 2008
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Radiocontrast Nephropathy Drug: N-Acetycysteine (NAC) Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients
Study Start Date : October 2007
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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

    Other Name: Acetadote

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780962

Contact: Stephen J Traub, MD 617.754.2347 straub@bidmc.harvard.edu

United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Stephen J Traub, MD    617-754-2347    straub@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Cumberland Pharmaceuticals
Principal Investigator: Stephen J Traub, MD Beth Israel Deaconess Medical Center, Boston
More Information

Responsible Party: Stephen J. Traub, MD, Beth Israel Deaconess Medical Center, Boston, MA
ClinicalTrials.gov Identifier: NCT00780962     History of Changes
Other Study ID Numbers: 2007P-000095
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: October 28, 2008
Last Verified: October 2008

Keywords provided by Beth Israel Deaconess Medical Center:
Radiocontrast Nephropathy
Computerized Tomography
Emergency Department
Safety of IV N-Acetylcysteine

Additional relevant MeSH terms:
Kidney Diseases
Disease Attributes
Pathologic Processes
Urologic Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs