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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00579995
First received: December 18, 2007
Last updated: June 25, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention
Preserving Kidney Function in People Who Are at High Risk of Developing Contrast-induced Nephropathy
 Drug: Oral N-Acetylcysteine
Drug: Intravenous Sodium Bicarbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

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

Estimated Enrollment: 140
Study Start Date: May 2005
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579995

Locations
United States, Nebraska
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-2265
Contact: Scott Shurmur, MD     402-559-5151     sshurmur@unmc.edu    
Contact: Andre P Bouhasin, MD     402-559-5151     abouhasi@unmc.edu    
Principal Investigator: Scott Shurmur, MD            
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Scott Shurmur, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Scott Shurmur, M.D., University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00579995     History of Changes
Other Study ID Numbers: 120-05-FB
Study First Received: December 18, 2007
Last Updated: June 25, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013