N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity
Phase 2
Completed
- Conditions
- Drug Induced Nephrotoxicity
- Registration Number
- NCT00267384
- Lead Sponsor
- Soroka University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The decrease in glomerular filtration rate (GFR)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel