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N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Victor Novack, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00267384
First received: December 16, 2005
Last updated: June 19, 2012
Last verified: June 2012

December 16, 2005
June 19, 2012
March 2006
May 2008   (final data collection date for primary outcome measure)
The decrease in glomerular filtration rate (GFR)
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Complete list of historical versions of study NCT00267384 on ClinicalTrials.gov Archive Site
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N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity
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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.

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Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Drug Induced Nephrotoxicity
Drug: Oral N-Acetylcysteine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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September 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
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Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00267384
sor407205ctil
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Victor Novack, Soroka University Medical Center
Soroka University Medical Center
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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
Soroka University Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP