Does the addition of long-acting subcutaneous insulin to the standard treatment of diabetic ketoacidosis reduce the time out of the acute phase?
Design
after providing a full explanation of the method and purpose of the research, the children's parents sign the consent form and the basic information is entered into a questionnaire. This information includes Age, weight, height, stage of puberty, history and severity of the disease .Patients are divided into one of the control and intervention groups using random block sampling method.Control group: receive short-term insulin drip (standard treatment).
Intervention groups: In addition to receiving standard short-term insulin drip, they receive a long-acting subcutaneous insulin dose of 0.5 units per kilogram of child weight.In both groups,Time out of the acute phase and the occurrence of complications are recorded. Leaving the acute phase, ie serum pH level> 7.3 and HCO3> 15mEq / L, normal serum electrolytes, alertness and no vomiting. Blood glucose levels are measured and recorded by the glucometer every hour and the patients' blood glucose, sodium, potassium and VBG are measured every three hours.The results are compared and statistically analyzed in two groups.
Settings and conduct
Patients in all groups will be admitted to PICU from the time of admission to the time of exit from the acute phase and will be monitored continuously for possible complications and will be treated in case of complications.
Participants/Inclusion and exclusion criteria
nclusion criteria:
1• The patient is between 2 and 15 years old.
2• Children with acute diabetic ketoacidosis :
o BS> 200 mg / dL
o PH <7.30
o HCO3 <15 mEq /L
o Urine ketone is positiv
Intervention groups
intervention groups: Adding two types of long-acting subcutaneous insulin to standard treatment of DKA
Main outcome variables
Time to exit the acute phase of diabetic ketoacidosis in hours
General information
Reason for update
Acronym
DKA
IRCT registration information
IRCT registration number:IRCT20201125049485N1
Registration date:2021-01-05, 1399/10/16
Registration timing:registered_while_recruiting
Last update:2021-01-05, 1399/10/16
Update count:0
Registration date
2021-01-05, 1399/10/16
Registrant information
Name
Victoria Chegini
Name of organization / entity
Qums
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 2476
Email address
victoria_che@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-11, 1399/08/21
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding long subcutaneous insulin to the standard treatment of diabetic ketoacidosis in children
Public title
Evaluation of the effect of adding long subcutaneous insulin to the standard treatment of diabetic ketoacidosis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 2 to 15 years old
acute diabetic ketoacidosis : BS> 200 mg / dL, PH <7.30 , HCO3 <15 mEq / L ,urinary ketone positive
Exclusion criteria:
• Reluctance to participate in the study
Age
From 2 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
All children with diatotic ketoacidosis who are referred to Qazvin Children's Hospital for treatment are included in the study based on inclusion and exclusion criteria. Then patients are assigned to one of the 3 treatment groups based on the block random allocation table which is randomly assigned to the software. Therefore, we have 18 blocks, in each block of 6, the number of patients assigned to each treatment group is equal to 2.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the clinical caregiver (physician and nurse) is aware of the intervention due to the registration of the intervention in the physician's instructions , But the researcher, data analyzer, and outcome assessor do not know which patient is in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
after providing a full explanation of the method and purpose of the research, the children's parents sign the consent form and the basic information is entered into a questionnaire. This information includes Age, weight, height, stage of puberty, history and severity of the disease . patients are divided into One of three groups of control and intervention using random block sampling method.Two intervention groups: Children who, in addition to receiving short-term standard insulin drip within the first 6 hours of treatment, receive a long-acting subcutaneous dose of Lantus or Detmirra at a rate of 0.5 units per kilogram of body weight .In both groups,Time out of the acute phase and the occurrence of complications are recorded , the duration of exit from the acute phase, the length of stay of the child in the intensive care unit and the occurrence of possible complications are reviewed and recorded. Exclusion from the acute phase in this study is a condition in which the serum level is PH> 7.3, HCO3> 15mEq / L, normal serum electrolytes, the patient is conscious and does not vomit. The serum level of patients' blood sugar is measured and recorded by the glucometer every hour and the level of blood sugar, sodium, potassium and VBG (Venus blood gas) of patients is measured and recorded by the laboratory every three hours. Finally, the collected data are compared with each other and the findings are reported. All patient information will remain confidential with the researchers and the findings of this study will be reported anonymously.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2020-11-11, 1399/08/21
Ethics committee reference number
IR.QUMS.REC.1399.315
Health conditions studied
1
Description of health condition studied
acute phase of diabetic ketoacidosis
ICD-10 code
E00-E89
ICD-10 code description
Endocrine, nutritional and metabolic diseases.
Primary outcomes
1
Description
Duration of exit from the acute phase of diabetic ketoacidosis.Exclusion from the acute phase in this study is a condition in which the serum level is PH> 7.30, HCO3> 15mEq / L, normal serum electrolytes, the patient is conscious and does not vomit
Timepoint
From the time of diagnosis of diabetic ketoacidosis to the time of exit from the acute phase
Method of measurement
Time to hour
Secondary outcomes
1
Description
Determining the average length of hospital stay in the PICU
Timepoint
From the beginning of hospitalization to the time of leaving the PICU
Method of measurement
Time to hour
2
Description
Evaluation of side effect from drug use during the study period: Hypoglycemia
Timepoint
From the beginning of the acute phase of diabetic ketoacidosis until the exit of the acute phase
Method of measurement
Frequent laboratory and glucotest monitoring of blood plasma
3
Description
Evaluation of side effects due to drug use during the study period: Hypokalemia
Timepoint
From the beginning of the acute phase of diabetic ketoacidosis until the exit of the acute phase
Method of measurement
Laboratory measurement of plasma potassium levels every three hours
4
Description
Cerebral edema
Timepoint
From starting treatment for diabetic ketoacidosis to having criteria for exiting the acute phase
Method of measurement
Have any signs or symptoms of high intracranial pressure on clinical examination and vital signs according to international standards
Intervention groups
1
Description
Intervention group 1: Children who in the first 6 hours of treatment, in addition to receiving short-term standard insulin drip, receive a long dose of subcutaneous insulin effect of Detmir with a rate of 0.5 units per kilogram of child weight .
Category
Treatment - Drugs
2
Description
Control group: Standard treatment for diabetic ketoacidosis in children, including short-acting intravenous insulin, is prescribed
Category
Treatment - Drugs
3
Description
Intervention group 2: Children who in the first 6 hours of treatment, in addition to receiving standard short-term insulin drip, receive a long-acting subcutaneous insulin dose of Lantus at a rate of 0.5 units per kilogram of child weight
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Children's Hospital
Full name of responsible person
Victoria Chegini
Street address
Shahid beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
4595-1-34159
Phone
+98 28 3333 4807
Fax
+98 28 3334 4088
Email
victoria_che@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Emamjomeh (Vice-Chancellor for Research and Technology Affairs)
Street address
Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Victoria Chegini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
4595-1-34159
Phone
+98 28 3333 4807
Email
victoria_che@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Victoria Chegini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
4595-1-34159
Phone
+98 28 3333 4808
Email
victoria_che@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Victoria Chegini
Position
Associate professo
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid beheshti blvd
City
Qazvin
Province
Qazvin
Postal code
4595-1-34159
Phone
+98 28 3333 4807
Email
victoria_che@yahoo.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
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
No - There is not a plan to make this available
Title and more details about the data/document
The course of treatment and the main outcome of the intervention and possible complications
When the data will become available and for how long
Simultaneously with the publication of the article
To whom data/document is available
Universities of Medical Sciences
Under which criteria data/document could be used
Mention the data source in future research
From where data/document is obtainable
Qazvin Children's Hospital
Hospital Research Center
Phone 0283333480
What processes are involved for a request to access data/document
Submitting a written request to the hospital research assistant