N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

Soroka University Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Drug Induced Nephrotoxicity

Treatments: Drug: Oral N-Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT00267384

sor407205ctil

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind