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NCT00267384 Clinical Trial

N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

Drug Induced Nephrotoxicity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00267384
Other study ID # sor407205ctil
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 16, 2005
Last updated June 19, 2012
Start date March 2006
Est. completion date September 2008

Study information
Verified date June 2012
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 2008
Est. primary completion date May 2008
Accepts healthy volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Oral N-Acetylcysteine

Locations
Country Name City State
Israel Soroka University Medical Center Beer-Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary The decrease in glomerular filtration rate (GFR)