A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate (PROTECt)
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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:
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Acute renal failure
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History of Kidney transplant
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Currently receiving N-acetylcysteine
_ Contraindication of hypersensitivity to N-acetylcysteine or sodium bicarbonate
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Left ventricular ejection fraction
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Pregnant, lactating females
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Allergy to contrast dye
Trial design
Primary purpose
Allocation
Interventional model
Masking
41 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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