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N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

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ClinicalTrials.gov Identifier: NCT00267384
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Victor Novack, Soroka University Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Drug Induced Nephrotoxicity Drug: Oral N-Acetylcysteine Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : March 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : September 2008

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The decrease in glomerular filtration rate (GFR)

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

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267384


Locations
Israel
Soroka University Medical Center
Beer-Sheva, Israel, POB 151
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Victor Novack, Head, Clinical research center, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00267384     History of Changes
Other Study ID Numbers: sor407205ctil
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by Victor Novack, Soroka University Medical Center:
Aminoglycosides

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
 Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes