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

Nephropathy Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00579995
• Other study ID #: 0120-05-FB
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2005
• Est. completion date: April 8, 2010

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: April 8, 2010
• Est. primary completion date: April 8, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Nephropathy

Intervention

Drug:
• Oral N-Acetylcysteine
600 milligrams (mg)
• 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

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years