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Comparison of the effectiveness of Dexamethasone and Antibiotic therapy with Antibiotic and Placebo therapy in prevention of Renal scarring in children with Acute Pyelonephritis

Protocol summary

Study aim
Effects of dexamethasone on renal infection
Design
In this research, 60 eligible patients referring with acute pyelonephritis were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups
Settings and conduct
Double blind study at the children ward in the Boali sina hospital
Participants/Inclusion and exclusion criteria
Children with acute pyelonephritis, age 3m to 12 y. exclusion previous renal anomaly.use of antibiotic and other organs disorder
Intervention groups
control group: antibiotic and placebo intervention group: antibiotic and dexamethasone
Main outcome variables
effect on the renal scar and urine cytokines

General information

Reason for update
Acronym
EARI
IRCT registration information
IRCT registration number: IRCT20110531006660N4
Registration date: 2017-12-27, 1396/10/06
Registration timing: retrospective

Last update: 2017-12-27, 1396/10/06
Update count: 0
Registration date
2017-12-27, 1396/10/06
Registrant information
Name
Javad Ghafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 0054
Email address
ghafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences, Sari,Iran
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2013-10-22, 1392/07/30
Actual recruitment end date
2014-12-10, 1393/09/19
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Dexamethasone and Antibiotic therapy with Antibiotic and Placebo therapy in prevention of Renal scarring in children with Acute Pyelonephritis
Public title
Effect of Antibiotic in Renal infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All of children with acute Pyelonephritis 3months to 12 years old
Exclusion criteria:
Previous urinary tract infection Urinary tract anomalies renal failure renal scar Consumed antibiotic
Age
From 3 months old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Individual Simple Randomization with table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Only the nurse that use drugs no blinded. But all of other people are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Effect of Steroid on the Renal Scaring

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moalem street , Moalem square
City
sari
Province
Mazandaran
Postal code
4815838477
Approval date
2013-08-08, 1392/05/17
Ethics committee reference number
1630

Health conditions studied

1

Description of health condition studied
children urinary tract infection
ICD-10 code
N00.9
ICD-10 code description
Acute nephritic syndrome with unspecified morphologic changes

Primary outcomes

1

Description
urinary IL6 and IL8 evaluate by ELISA
Timepoint
before and after treatment
Method of measurement
laboratory

2

Description
renal scaring
Timepoint
befor and 4 month after treatment
Method of measurement
isotop scan

Secondary outcomes

1

Description
drug side effects
Timepoint
during treatment
Method of measurement
Observation

Intervention groups

1

Description
Dexamethasone o.15 mg/kg q6h and Ceftriaxone 80 mg/kg/day in intervention group for 4 days
Category
Treatment - Drugs

2

Description
Control group: 80 mg/kg/day ceftriaxone and placebo ( normal saline) in control group fot 4 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Boalisina hospital
Full name of responsible person
Javad Ghaffari
Street address
Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3018
Email
Javadneg@yahoo.com

2

Recruitment center
Name of recruitment center
Boalisina hospital
Full name of responsible person
Javad Ghaffari
Street address
Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3018
Email
Javadneg@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Reza Alizadeh Navaei
Street address
Moalem Sqaure
City
Sari
Province
Mazandaran
Postal code
4815858477
Phone
+98 11 3325 7230
Email
Reza_nava@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Javad Ghaffari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy
Street address
Boalisina Hospital
City
Sari
Province
Mazandaran
Postal code
4815858477
Phone
+98 11 3326 0054
Fax
Email
Javadneg@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Javad Ghaffari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy and clinical immunology
Street address
Boalisina Hospital
City
Sari
Province
Mazandaran
Postal code
4815858477
Phone
+98 11 3326 0054
Fax
Email
Javadneg@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Javad Ghaffari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy and clinical immunology
Street address
Moalem St,Moalem Squar
City
Sari
Province
Mazandaran
Postal code
4815858477
Phone
+98 11 3326 0054
Fax
Email
Javadneg@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of data to be share after deidentified IPD.
When the data will become available and for how long
from 2018
To whom data/document is available
All people
Under which criteria data/document could be used
No limitation
From where data/document is obtainable
javadneg@yahoo.com
What processes are involved for a request to access data/document
quickly
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