Using novel biomarkers for detection and comparison of nephrotoxicity induced by various doses of amikacin in geriatric critically ill patients: A randomized clinical trial
objective: to evaluate and comparison of nephrotoxicity induced by different doses of amikacin in geriatric critically ill patients.
inclusion criteria: age equal to or more than 65 years;
Sr cr equal to or less than 1.2 mg/dl;
documented or suspicious gram negative sepsis;
Exclusion criteria:
renal failure;
need for amikacin dosing adjustment;
method:
patients devided to 2 groups. on group recieve amikacin by dose of 25 mg/kg and another group recieve amikacin by 15 mg/kg dose. amikacin administered to patients for a minimum of 10 days and serum and urine samples foe mesurment of nephrotoxicity biomarkers and serum creatinin will be collected on baseline and days : 3, 5 ,7, 10.
patients were analysed based on the rise in serum and urine biomarkers which can be a specific detector of renal damage.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091110817N1
Registration date:2013-01-24, 1391/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-24, 1391/11/05
Registrant information
Name
Kourosh Sadeghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8849 1340
Email address
sadeghik@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Using novel biomarkers for detection and comparison of nephrotoxicity induced by various doses of amikacin in geriatric critically ill patients: A randomized clinical trial
Public title
Detection of amikacin nephrotoxicity with novel markers
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics comitee of Tehran University of Medical Sciences
Street address
Tehran University of Medical sciences, enghelab Sq, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-11-18, 1391/08/28
Ethics committee reference number
91-03-33-19352-70727
Health conditions studied
1
Description of health condition studied
sepsis
ICD-10 code
A 41.5
ICD-10 code description
Sepsis due to other Gram-negative organisms
Primary outcomes
1
Description
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 outcomes
1
Description
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
Intervention groups
1
Description
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 and days 3.5.7. and 10 of the study
Category
Treatment - Drugs
2
Description
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;es will be collected on baseline and days 3,5,7, and 10 for analysis.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital- ICU general and ICU emergency wards- Tehran
Full name of responsible person
Mojtana Mojtahedzadeh
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital- Internal ICU- Tehran
Full name of responsible person
Kourosh Sadeghi
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Shohada hospital- ICU- Tabriz, Iran
Full name of responsible person
Hadi Hamishehkar
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Saeedi
Street address
Vice Chancellor for Research- Tehran University of Medical Sciences- Keshavarz Blvd. Ghods St. TUMS central organization building. 4th floor.Research management department.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kourosh Sadeghi
Position
Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
Department of Clinical Pharmacy- School of Pharmacy- Tehran University of Medical Sciences- Enghelab Sq. Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
sadeghik@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Professoe Mojtaba Mojtahedzadeh
Position
clinical Professor of Pharmacotherapy
Other areas of specialty/work
Street address
School of Pharmacy and Sina Hospital, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
mojtahed@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kourosh Sadeghi
Position
Clinical Pharmacy Resident
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)