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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00579995
Other study ID # 0120-05-FB
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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