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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Drug Induced Nephrotoxicity | Drug: Oral N-Acetylcysteine | Phase 2 Phase 3 |
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 |

- The decrease in glomerular filtration rate (GFR)

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- 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.
- Aged between 18 and 90.
- Recruitment time between starting gentamycin therapy and initiation of the study intervention will be less than 24 hours.
- Signed informed consent.
Exclusion Criteria:
- Any known allergy or intolerance to one of the medications in the AG group.
- Any known allergy or intolerance to N-acetylcysteine.
- Any immunosuppressive therapy excluding steroid therapy.
- Pregnancy.
- HIV infection.
- Non-sepsis-related neutropenia.
- An estimated creatinine clearance of less than 30 mL/min.
- Acute renal failure defined as elevation in creatinine level of 0.5 mg/dL above the patient's baseline.

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
Israel | |
Soroka University Medical Center | |
Beer-Sheva, Israel, POB 151 |
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 |
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 |