Nephropathy Clinical Trial
— PROTECtOfficial 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
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 |
Verified date | August 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Unversity of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
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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