N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00780962
First received: October 27, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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 Intervention Phase
Radiocontrast Nephropathy
Drug: N-Acetycysteine (NAC)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: October 2007
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780962

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

Locations
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
Investigators
Principal Investigator: Stephen J Traub, MD Beth Israel Deaconess Medical Center, Boston
  More Information

No publications provided

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
Study First Received: October 27, 2008
Last Updated: October 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
NAC
Radiocontrast Nephropathy
N-Acetycysteine
RCN
RCIN
Creatinine
Computerized Tomography
CT
Emergency Department
ED
Safety of IV N-Acetylcysteine

Additional relevant MeSH terms:
Emergencies
Kidney Diseases
Disease Attributes
Pathologic Processes
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014