A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate (PROTECt)

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. Identifier: NCT00579995
Recruitment Status : Unknown
Verified June 2010 by University of Nebraska.
Recruitment status was:  Recruiting
First Posted : December 24, 2007
Last Update Posted : June 28, 2010
Information provided by:
University of Nebraska

December 18, 2007
December 24, 2007
June 28, 2010
May 2005
January 2011   (Final data collection date for primary outcome measure)
to compare the effectiveness of two medications, oral N-acetylcysteine (mucomyst) and intravenous sodium bicarbonate, used to protect the kidneys from contrast injury during a cardiac catheterization [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00579995 on Archive Site
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Not Provided
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A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate
A Prospective, Randomized Trial Comparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Cardiac Catheterization
The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of CIN after cardiac catheterization.
It is thought that N-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. N-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form S-nitrosothiol, a more stable form and potent vasodilator. It also increases the expression of nitric oxide synthesis and may improve blood flow. Oxidants activate a signal-transduction cascade and molecular response that may initiate the cell-death pathway. These pathways seem to be sensitive to the redox state of the cell and are inhibited by N-acetylcysteine, which promotes pathways that lead to repair and survival whenever cells are under oxidant stress.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Preserving Kidney Function in People Who Are at High Risk of Developing Contrast-induced Nephropathy
  • Drug: Oral N-Acetylcysteine
    600 mg
    Other Names:
    • NAC
    • N-Acetyl-L-Cysteine
  • Drug: Intravenous Sodium Bicarbonate
    3mL/kg/hr for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure
    Other Names:
    • Sodium hydrogen carbonate
    • sodium acid carbonate
    • baking soda
    • bicarbonate of soda CAS No.: 144-55-8
  • No Intervention: 1, oral N-Acetylcysteine
    Intervention: Drug: Oral N-Acetylcysteine
  • No Intervention: 2, Intravenous Sodium Bicarbonate
    Intervention: Drug: Intravenous Sodium Bicarbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria: 19 years of age

  • Baseline serum creatinine or
  • Calculated creatinine
  • Stable Renal Function
  • Left Ventricular ejection fraction
  • Non-pregnant, non-lactating females (all women of childbearing potential must have a negative serum pregnancy test. No contraception will be required
  • Able to sign informed consent

Exclusion Criteria:

  • Acute renal failure
  • History of Kidney transplant
  • Currently receiving N-acetylcysteine

    _ Contraindication of hypersensitivity to N-acetylcysteine or sodium bicarbonate

  • Left ventricular ejection fraction
  • Pregnant, lactating females
  • Allergy to contrast dye
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Scott Shurmur, M.D., University of Nebraska Medical Center
University of Nebraska
Not Provided
Principal Investigator: Scott Shurmur, MD University of Nebraska
University of Nebraska
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP