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Comparison of the effects of Normal-saline and Half-saline in the treatment of children with diabetic ketoacidosis

Protocol summary

Study aim
Comparison of time to exit from DKA,comparison of blood sugar changes,comparison of electrolyte changes,comparison of the number of patients who will have cerebral edema symptoms in the two study groups
Design
Clinical trial study, two intervention groups, parallel groups, randomized using RAS (Random Allocation Software) on 40 patients
Settings and conduct
The patients will be randomly divided into two groups using RAS software, two groups, 'Normal saline' and 'Half-saline', and homogenization will be done based on the age of the patients, and the treatment of each group will be based on the dka treatment guidelines. including compensating the lost volume and correcting acidosis and blood sugar with two different types of serum, and the treatment results of the two groups, including the time to correct acidosis, the time to correct hyperglycemia and electrolyte disturbances, the symptoms of cerebral edema, and the results of the study to choose the preferred serum more will be obtained in the treatment of dka patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed with diabetic ketoacidosis Blood sugar above 200 Metabolic acidosis with ph below 7.3 Bicarbonate below 15 ketonuria No referral from other centers Exit criteria: The presence of electrolyte disorders, including serum sodium above 150 or below 130 upon arrival
Intervention groups
Patients with type 1 diabetes
Main outcome variables
Comparison of time to discharge from DKA in two groups Comparison of blood sugar changes of patients in two groups Comparison of electrolyte changes in two groups Comparison of the number of patients who will have cerebral edema symptoms in two groups

General information

Reason for update
Acronym
DKA(Diabetic ketoacidosis)
IRCT registration information
IRCT registration number: IRCT20231025059849N1
Registration date: 2024-01-12, 1402/10/22
Registration timing: prospective

Last update: 2024-01-12, 1402/10/22
Update count: 0
Registration date
2024-01-12, 1402/10/22
Registrant information
Name
Siamak Shiva
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3159 2105
Email address
shivas@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Normal-saline and Half-saline in the treatment of children with diabetic ketoacidosis
Public title
Comparison of the effects of Normal-saline and Half-saline in the treatment of children with diabetic ketoacidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age under 18years Blood suger obove 250 Ph< 7.3 Hco3< 18 Ketonuria
Exclusion criteria:
Blood Sodium level above 150 Blood sodium level umder 130 Referral patients from other centers
Age
To 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of flip the coin
Blinding (investigator's opinion)
Single blinded
Blinding description
Study participants will be unaware of which study group they are in. In order to prevent bias, all participants will be randomly divided into two groups, 'Normal saline' and 'Half-saline', using RAS (Random Allocation Software) software, and homogenization will be done based on the age of the patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz / Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 Third Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5367153124
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.TBZMED.REC.1402.729

Health conditions studied

1

Description of health condition studied
Diabet mellitus-DKA
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Correction of acidosis
Timepoint
In 24 hours after addmition
Method of measurement
chek of vbg every 2 hours

2

Description
Blood electrolyte changes
Timepoint
Every two hours
Method of measurement
blood test

3

Description
Blood sugar changes
Timepoint
every hour
Method of measurement
Blood sugar test

Secondary outcomes

1

Description
Brain edema symptom
Timepoint
Frequent examination every 2 hours
Method of measurement
Examining clinical symptoms including changes in level of consciousness, headache and anisocoria

Intervention groups

1

Description
Intervention group1: Group treated with normal saline serum
Category
Treatment - Drugs

2

Description
Intervention group2: Group treated with half saline serum
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mardani Azar Children's Hospital
Full name of responsible person
Dr shiva , siamak
Street address
Mardani Azar Children's Hospital, Khavaran town, Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5367153124
Phone
+98 41 3159 5050
Fax
+98 41 3159 5050
Email
mardaniazar@tbzmed.ac.ir
Web page address
https://mardaniazari.tbzmed.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Tabriz / Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5367153124
Phone
+98 41 3159 5050
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Shiva, Siamak
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mardani azar Children Hospital, khavaran town,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5367153124
Phone
+98 41 3159 5050
Email
Shivas@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr shiva , siamak
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Mardani Azar Children's Hospital, Khavaran town, Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5367153124
Phone
0984131595050
Email
Shivas@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr shiva , siamak
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Mardani Azar Children's Hospital, Khavaran town, Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5367153124
Phone
0984131595050
Email
Shivas@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of information
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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