N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Drug Induced Nephrotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oral N-Acetylcysteine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No