A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate
- Conditions
- Nephropathy
- Interventions
- Registration Number
- NCT00579995
- Lead Sponsor
- University of Nebraska
- Brief 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.
- Detailed 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 & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
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
-
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description N-Acetylcysteine Oral N-Acetylcysteine Oral N-Acetylcysteine 600 mg Sodium Bicarbonate Sodium Bicarbonate Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure
- Primary Outcome Measures
Name Time Method Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy 2 years Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unversity of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States