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A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate

Not Applicable
Terminated
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
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
N-AcetylcysteineOral N-AcetylcysteineOral N-Acetylcysteine 600 mg
Sodium BicarbonateSodium BicarbonateSodium 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
NameTimeMethod
Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy2 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
NameTimeMethod

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

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