Detection of amikacin nephrotoxicity with novel markers

Not Applicable

• Conditions: sepsis.; Sepsis due to other Gram-negative organisms; A 41.5

• Registration Number: IRCT2012091110817N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

age equal to or more than 65; serum creatinin equal to or less than 1.2 or estimated GFR equal to or more than 40 ml/min; sepsis with gram negative or unknown microorganism in geriatric patients addmited in ICU and need for an aminoglycoside and no history of aminoglycoside administration in the last 30 days. Exclusion criteria: age less than 65; aminoglycoside administration in the last 30 days; BMI more than 35; Allergy to aminoglycosides; amikacin administration less than 5 days; trouph levels more than 10 mcg/ml; need for amikacin dose adjustment during study period; neoplasm diagnisis with chemotherapy or radiotherapy history; viral hepatitis; moderate to severe renal failure considering normal decline in GFR with aging ( Scr more than 1.2); life expectancey less than 48 hours and APACHE II score more than 35.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Akutre kidney injury incidence. Timepoint: baseline and during drug administration on days: 3, 5 , 7, 10. Method of measurement: measurment of AKI biomarkers and serum creatinine.

Secondary Outcome Measures

Name	Time	Method
Survival after 28 days post intervention in two groups. Timepoint: 28 days after initiation of study. Method of measurement: report of survival or mortality on day 28.