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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preserving Kidney Function in People Who Are at High Risk of Developing Contrast-induced Nephropathy Drug: Oral N-Acetylcysteine Drug: Intravenous Sodium Bicarbonate Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : May 2005
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1, oral N-Acetylcysteine Drug: Oral N-Acetylcysteine
600 mg
Other Names:
  • NAC
  • N-Acetyl-L-Cysteine
No Intervention: 2, Intravenous Sodium Bicarbonate 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

Primary Outcome Measures :
  1. 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 ]

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:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00579995

United States, Nebraska
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-2265
Contact: Scott Shurmur, MD    402-559-5151   
Contact: Andre P Bouhasin, MD    402-559-5151   
Principal Investigator: Scott Shurmur, MD         
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Scott Shurmur, MD University of Nebraska

Responsible Party: Scott Shurmur, M.D., University of Nebraska Medical Center Identifier: NCT00579995     History of Changes
Other Study ID Numbers: 120-05-FB
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: June 2010

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