Status:
COMPLETED
N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity
Lead Sponsor:
Soroka University Medical Center
Conditions:
Drug Induced Nephrotoxicity
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00267384
Start Date
March 1 2006
End Date
September 1 2008
Last Update
June 20 2012
Active Locations (1)
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1
Soroka University Medical Center
Beersheba, Israel, POB 151