The general aim of the study is to determine the effect of dexamethasone injection in the first 24 hours in preventing scar formation in patients with pyelonephritis.
Design
In this randomized, prospective, double-blind clinical trial study, children will be placed according to the row of the list in such a way that children with even rows will be placed in group A and children with odd rows will be placed in group B. Basically, double blocks (AB) will be formed.
Settings and conduct
This study will be conducted in the children's department of Sanandaj Mission Hospital in children aged 1 to 12 years with proven acute pyelonephritis (APN) in both groups A and B. In group A, in addition to routine care, a 3-day course of intravenous corticosteroids (dexamethasone 0.30 mg/kg/day) twice a day, and group B will not receive any medication other than routine care.
Participants/Inclusion and exclusion criteria
The inclusion criteria include children aged 1 month to 12 years with the first episode of fever T > 38°C and having a urinary tract infection and a positive urine culture, the presence of a positive urine culture, which according to the definition includes at least 10000 CFUs/mL from a clean sample obtained with a urine bag. or at least 10000 CFUs/mL from the sample obtained by catheterization or the growth of any amount of bacteria from the sample obtained by suprapubic aspiration. Exclusion criteria included endocrine disease, known immunosuppressive therapy, cancer or uropathy, and those who had an abnormal DMSA before late assessment (at least 6 months follow-up) and had a second UTI.
Intervention groups
Study participants in group A will receive dexamethasone (0.15 mg/kg per dose every 12 hours for 4 days) in addition to usual care, and group B will receive only usual care.
Main outcome variables
Scar formation; Possible side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231226060526N1
Registration date:2024-02-13, 1402/11/24
Registration timing:prospective
Last update:2024-02-13, 1402/11/24
Update count:0
Registration date
2024-02-13, 1402/11/24
Registrant information
Name
Syed Zia Hejazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3361 8356
Email address
szhejazi1402@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of dexamethasone injection in the first 24 hours in preventing kidney scaring in children with pyelonephritis
Public title
Investigating the effect of dexamethasone injection in the first 24 hours in preventing kidney scaring in children with pyelonephritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children from 1 month to 12 years with first episode of fever T > 38°C
having a urinary tract infection and a positive urine culture
The presence of a positive urine culture, which according to the definition includes at least 100000 CFUs/mL from a clean sample obtained with a urine bag, or at least 10000 CFUs/mL from a sample obtained by catheterization, or the growth of any amount of bacteria from a sample obtained by suprapubic aspiration.
Exclusion criteria:
Endocrine disease
Immunosuppressive therapy
Known cancer or uropathy
Those who had an abnormal DMSA before late assessment (at least 6 months follow-up) had a second UTI.
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size was calculated based on the study of Liviana Da Dalt et al., which had 42 people in each group and assumed a 20% difference in scar formation in the two groups (in other words, a 20% reduction in scar formation in the group receiving dexamethasone) and with the following assumptions: 49 people were obtained in each group, and to increase the accuracy of the study, 50 people in each group and a total of 100 people are included in this study.
Children according to the row of the list in such a way that children with even rows will be placed in group A and children with odd rows will be placed in group B. Double blocks (AB) will be formed.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the grouping, the patient care team will inject drugs and placebos to the patients of the designated groups according to the instructions, and the researcher and the patient will not be informed about the status of the grouping and the type of drug prescribed in the group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Approval date
2023-08-22, 1402/05/31
Ethics committee reference number
IR.MUK.REC.1402.161
Health conditions studied
1
Description of health condition studied
Acute pyelonephritis
ICD-10 code
N13.7
ICD-10 code description
Vesicoureteral-reflux
Primary outcomes
1
Description
Primary outcome of presence of renal scar in Dimercaptosuccinic acid renal scan
Timepoint
6-month follow-up
Method of measurement
Dimercaptosuccinic acid (DMSA) renal scan
Secondary outcomes
1
Description
The presence of kidney scar in children groups A and B with higher Procalcitonin and the acceptability of steroid adjuvant in terms of the amount of treatment and side effects
Timepoint
6-month follow-up
Method of measurement
Dimercaptosuccinic acid (DMSA) renal scan
Intervention groups
1
Description
Control group: They will receive only routine care
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sanandaj Mission Hospital
Full name of responsible person
Seyyed Zia Hijazi
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6619667761
Phone
+98 87 3361 8356
Email
szhejazi1402@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Melki
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 6664 6582
Email
szhejazi1402@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Seyyed Zia Hijazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Keshavarz Street
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 6664 6580
Email
szhejazi1402@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Seyed Zia Hejazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Keshavarz Street
City
Sanandaj
Province
Kurdistan
Postal code
6619667761
Phone
+98 87 3328 5912
Email
szhejazi1402@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sayed Zia Hejazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Keshavarz Street
City
Sanandaj
Province
Kurdistan
Postal code
6619667763
Phone
+98 87 3328 5912
Email
szhejazi1402@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data file will be shareable after the approval of the research vice-chancellor of the faculty.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no specific case.
From where data/document is obtainable
ziahejazi1933@gmail.com
What processes are involved for a request to access data/document
After receiving the application, the application will be submitted to the research vice-chancellor of the university, and if approved, the necessary information will be sent via email.