Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
0120-05-FB
Description
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.
Trial arms
Trial start
2005-05-01
Estimated PCD
2010-04-08
Trial end
2010-04-08
Status
Terminated
Treatment
Oral N-Acetylcysteine
600 milligrams (mg)
Arms:
N-Acetylcysteine
Other names:
N-Acetyl-L-Cysteine
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
Arms:
Sodium Bicarbonate
Other names:
Sodium hydrogen carbonate, sodium acid carbonate, baking soda
Size
41
Primary endpoint
Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
2 years
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 41, 'type': 'ACTUAL'}}
Updated at
2023-09-21

1 organization

2 products

1 indication

Organization
University of Nebraska
Product
N-Acetylcysteine
Indication
Kidney Disease
Product
Sodium Bicarbonate