Omaha, Nebraska 68198


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.


Study summary:

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.


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


Study is Available At:


Original ID:

120-05-FB


NCT ID:

NCT00579995


Secondary ID:


Study Acronym:

PROTECt


Brief Title:

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


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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Nebraska


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

140


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Scott Shurmur, MD
Principal Investigator
University of Nebraska

Study Dates

Start Date:May 2005
Completion Date:January 2011
Completion Type:Anticipated
Primary Completion Date:January 2011
Primary Completion Type:Anticipated
Verification Date:June 2010
Last Changed Date:June 25, 2010
First Received Date:December 18, 2007

Study Outcomes

Outcome Type: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Oral N-Acetylcysteine
Description:600 mg
Arm Name:1, oral N-Acetylcysteine
Other Name:NAC
Intervention Type:Drug
Name:Intravenous Sodium Bicarbonate
Description:3mL/kg/hr for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure
Arm Name:2, Intravenous Sodium Bicarbonate
Other Name:Sodium hydrogen carbonate

Study Arms

Study Arm Type:No Intervention
Arm Name:1, oral N-Acetylcysteine
Study Arm Type:No Intervention
Arm Name:2, Intravenous Sodium Bicarbonate

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Nebraska

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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