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

Primary Purpose

Nephropathy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral N-Acetylcysteine
Sodium Bicarbonate
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nephropathy focused on measuring contrast induced nephropathy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Unversity of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

N-Acetylcysteine

Sodium Bicarbonate

Arm Description

Oral N-Acetylcysteine 600 mg

Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure

Outcomes

Primary Outcome Measures

Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2007
Last Updated
August 26, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT00579995
Brief Title
A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate
Acronym
PROTECt
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 Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Technical measurement problems led to unreliable or uninterpretable data.
Study Start Date
May 1, 2005 (Actual)
Primary Completion Date
April 8, 2010 (Actual)
Study Completion Date
April 8, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephropathy
Keywords
contrast induced nephropathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-Acetylcysteine
Arm Type
Active Comparator
Arm Description
Oral N-Acetylcysteine 600 mg
Arm Title
Sodium Bicarbonate
Arm Type
Active Comparator
Arm Description
Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure
Intervention Type
Drug
Intervention Name(s)
Oral N-Acetylcysteine
Other Intervention Name(s)
N-Acetyl-L-Cysteine
Intervention Description
600 milligrams (mg)
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate
Other Intervention Name(s)
Sodium hydrogen carbonate, sodium acid carbonate, baking soda
Intervention Description
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
Primary Outcome Measure Information:
Title
Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
Description
Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Shurmur, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

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

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