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Detection of amikacin nephrotoxicity with novel markers

Using novel biomarkers for detection and comparison of nephrotoxicity induced by various doses of amikacin in geriatric critically ill patients: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012091110817N1
Enrollment
40
Registered
2013-01-24
Start date
2012-06-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis. Sepsis due to other Gram-negative organisms

Interventions

Intervention 1: patients devided in 2 groups and in one group (high dose group) amikacin by dose of 25 mg/kg based on IBW will be administered to the patients. serum and urine samples will be collecte
es will be collected on baseline and days 3,5,7, and 10 for analysis.
Treatment - Drugs
patients devided in 2 groups and in one group (high dose group) amikacin by dose of 25 mg/kg based on IBW will be administered to the patients. serum and urine samples will be collected on baseline an
In second group ( standard dose group) amikacin by dose of 15 mg/kg based on IBW will be administered for the patients for 10 days and serum and urine sampl

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKourosh Sadeghi

Tehran University of Medical Sciences

sadeghik@razi.tums.ac.ir+98 21 6695 4709

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026