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

August 26, 2023 updated by: University of Nebraska

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 Contrast-Induced Nephropathy (CIN) after cardiac catheterization.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Unversity of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: N-Acetylcysteine
Oral N-Acetylcysteine 600 mg
Drug: Oral N-Acetylcysteine
600 milligrams (mg)
Other Names:
  • N-Acetyl-L-Cysteine
Active Comparator: Sodium Bicarbonate
Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure
Drug: Sodium Bicarbonate
3 milliliters per kilogram per hour (mL/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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
Time Frame: 2 years
Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Scott Shurmur, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2005

Primary Completion (Actual)

April 8, 2010

Study Completion (Actual)

April 8, 2010

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimated)

December 24, 2007

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

August 26, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-05-FB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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