Study of the difference of renal complications in single and double daily dose of Amikacin in patients with neonatal sepsis in Imam Khomeini Hospital in Tehran: A double blind clinical trial
The evaluation of the difference of renal complications in single and double daily dose of Amikacin in patients with neonatal sepsis in Imam Khomeini Hospital in Tehran
Design
Clinical trial of two parallel groups, without control group, double-blind, randomized, phase 3, on 90 patients, block randomization with 2 alleles and 4 sizes
Settings and conduct
This study was performed in Imam Khomeini Hospital in Tehran during one year (July 2018 to July 2019). After block randomization and bilateral blinding, the first group received 15 mg / kg amikacin daily and the second group received 10 mg / kg twice daily. Before and after seven days of treatment, the following indicators were determined and compared in two groups: GFR, serum creatinine level, creatinine clearance, FEMg.
Participants/Inclusion and exclusion criteria
Infants with sepsis without asphyxia and congenital renal anomalies
Intervention groups
the first group received 15 mg/kg Amikacin daily and the second group received 10 mg/kg twice daily
Main outcome variables
Renal complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201212049686N1
Registration date:2021-01-18, 1399/10/29
Registration timing:retrospective
Last update:2021-01-18, 1399/10/29
Update count:0
Registration date
2021-01-18, 1399/10/29
Registrant information
Name
Mojtaba Fazel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2240
Email address
mojtabafazel@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
2019-07-13, 1398/04/22
Actual recruitment end date
2020-07-08, 1399/04/18
Trial completion date
2020-10-16, 1399/07/25
Scientific title
Study of the difference of renal complications in single and double daily dose of Amikacin in patients with neonatal sepsis in Imam Khomeini Hospital in Tehran: A double blind clinical trial
Public title
Renal complications of Amikacin in patients with neonatal sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with neonatal sepsis
Parental consent to participate in the study
Exclusion criteria:
incomplete treatment
parental dissatisfaction with continuing treatment
evidence of asphyxia
renal abnormalities at birth
Age
From 3 days old to 1 month old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups using block randomization. The number of samples assigned to each of the study groups and the size of the blocks were equal. Random allocation concealment was performed using Excel random number table and from the beginning of sampling, neonates with sepsis were coded according to the date of admission and were placed in each of the two groups according to random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, who was a newborn, did not know which group he was in, and the clinical caregiver and the researcher were blinded to the dose of the drug and the assignment of each patient to each group. The data analyzer and outcome assessor were also unaware of patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Gharib St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733134
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.014
Health conditions studied
1
Description of health condition studied
neonatal Sepsis
ICD-10 code
D50-D89
ICD-10 code description
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Primary outcomes
1
Description
GFR above 30%
Timepoint
Before and after seven days of treatment
Method of measurement
First, serum creatinine level was measured and GFR was calculated using the Schwartz formula: Creatinine clearance in millimeters per minute per 1/73 square meter of body surface =height in cm * K/ serum creatinine (in this formula: K in premature infants up to one year of age 0.33%, in infants Semester up to one year is 0.45%)
Secondary outcomes
1
Description
Creatinine clearance
Timepoint
before one one week after Amikacin administration
Method of measurement
First, serum and urine creatinine were calculated and the creatinine clearance was calculated using the following formula: Urine creatinine * Urine volume / Serum creatinine
Intervention groups
1
Description
Intervention group: the first group received 15 mg/kg Amikacin once daily. Intravenous administration of amikacin made by Caspian Iran Company was performed for 7 days.
Category
Treatment - Drugs
2
Description
Intervention group: group received 10 mg/kg of Amikacin twice daily. Intravenous administration of amikacin made by Caspian Iran Company was performed for 7 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mojtaba Fazel
Street address
Gharib St.
City
Tehran
Province
Tehran
Postal code
1419733134
Phone
+98 21 6119 2240
Email
mojtabafazel@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ali Sahraian
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733134
Phone
+98 21 6119 2240
Email
msahrai@sina.tums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Fazel
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics Nephrology
Street address
Gharib St.
City
Tehran
Province
Tehran
Postal code
1419733134
Phone
+98 21 6119 2240
Email
mojtabafazel@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Fazel
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Prdiatrics Nephrology
Street address
Gharib St.
City
Tehran
Province
Tehran
Postal code
1419733134
Phone
+98 21 6119 2240
Email
mojtabafazel@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Fazel
Position
Assistant Proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics Nephrology
Street address
Gharib St.
City
Tehran
Province
Tehran
Postal code
1419733134
Phone
+98 21 6119 2240
Email
mojtabafazel@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data obtained from the study process recorded in the questionnaires and SPSS software will be provided to the journal if necessary for the submission of the article or at the request of the journal reviewer.
When the data will become available and for how long
From the time of article submission until any time after which data needs to be provided.
To whom data/document is available
If the journal is required to provide data in a supplementary file, all persons can access the data, and if the journal has requested the data, the reviewers and the journal editorial team can access it.
Under which criteria data/document could be used
The data can be used to review the journal's referees upon request, and if requested as a supplemental file by the journal, all researchers can use the data to study or use in their future studies.
From where data/document is obtainable
Dr. Mojtaba Fazel and Dr. Seyed Alireza Adel Barkhordar
Imam Khomeini Hospital, Tehran - Children and NICU Ward
E-mail: mojtabafazel@yahoo.com
What processes are involved for a request to access data/document
The requesting person gives an email to the given address explaining the reason for requesting access to the data and how to use the data. A letter of commitment form stating that the data will not be misused and violated copyright law will be signed by the applicant. After reviewing the request and consulting with the project partners, if the request is approved, data will be provided within 2-3 weeks.