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N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

This study has been completed.
Information provided by (Responsible Party):
Victor Novack, Soroka University Medical Center Identifier:
First received: December 16, 2005
Last updated: June 19, 2012
Last verified: June 2012
This randomized, double-blind, placebo-controlled clinical trial will be performed to assess the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients hospitalized with an infection and treated with aminoglycosides (AGs). Secondary goals of the study will be as follows: comparison of the mortality rates, and length of hospitalization among patients treated with N-acetylcysteine compared to the control group.

Condition Intervention Phase
Drug Induced Nephrotoxicity
Drug: Oral N-Acetylcysteine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Victor Novack, Soroka University Medical Center:

Primary Outcome Measures:
  • The decrease in glomerular filtration rate (GFR)

Study Start Date: March 2006
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Patients hospitalized with presumptive gram-negative infection, as assessed by the treating house staff and requiring gentamycin therapy according to an infectious disease specialist decision.
  2. Aged between 18 and 90.
  3. Recruitment time between starting gentamycin therapy and initiation of the study intervention will be less than 24 hours.
  4. Signed informed consent.

Exclusion Criteria:

  1. Any known allergy or intolerance to one of the medications in the AG group.
  2. Any known allergy or intolerance to N-acetylcysteine.
  3. Any immunosuppressive therapy excluding steroid therapy.
  4. Pregnancy.
  5. HIV infection.
  6. Non-sepsis-related neutropenia.
  7. An estimated creatinine clearance of less than 30 mL/min.
  8. Acute renal failure defined as elevation in creatinine level of 0.5 mg/dL above the patient's baseline.
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Please refer to this study by its identifier: NCT00267384

Soroka University Medical Center
Beer-Sheva, Israel, POB 151
Sponsors and Collaborators
Soroka University Medical Center
Principal Investigator: Ohad Etzion, MD Internal Medicine Division, Soroka University Medical Center
Principal Investigator: Victor Novack, MD, PhD Internal Medicine Division, Soroka University Medical Center
  More Information

Responsible Party: Victor Novack, Head, Clinical research center, Soroka University Medical Center Identifier: NCT00267384     History of Changes
Other Study ID Numbers: sor407205ctil
Study First Received: December 16, 2005
Last Updated: June 19, 2012

Keywords provided by Victor Novack, Soroka University Medical Center:

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes processed this record on May 25, 2017