Comparison of the effect of norepinephrine with and without dobutamine on mortality and morbidity of children with septic shock admitted to the intensive care unit
Comparison of the effect of norepinephrine with and without dobutamine in mortality and morbidity of children with septic shock hospitalized in the intensive care unit
Design
Clinical trial with two intervention groups, with parallel groups, single-blind, randomized, phase 2 on 40 patients. R statistical software is used for block randomization.
Settings and conduct
This clinical trial, which is conducted in Shahid Bahoner Hospital, Kerman, on 40 children with septic shock admitted to the intensive care unit, is a single-blind study, so that the results are checked by an anesthetist, nurse, and uninformed laboratory personnel.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children in the age group of 2 to 14 years
children with septic shock
They need to transfer to the intensive care unit
Non-inclusion criteria: Children with organ failure
The patient's lack of consent, or if the patient is unable to answer, the patient's guardian's lack of consent
The presence of heart failure, kidney and diabetes
Intervention groups
The first intervention group receives norepinephrine in addition to common supportive measures, and the second group receives norepinephrine with dobutamine.
Main outcome variables
Hospitalization period; number of days dependent on vasopressor; Hemodynamic and perfusion findings (CO-MAP-HR); serum lactate level; Electrolytes (urea and creatinine)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101220005426N13
Registration date:2023-01-26, 1401/11/06
Registration timing:registered_while_recruiting
Last update:2023-01-26, 1401/11/06
Update count:0
Registration date
2023-01-26, 1401/11/06
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-23, 1401/11/03
Expected recruitment end date
2023-02-22, 1401/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of norepinephrine with and without dobutamine on mortality and morbidity of children with septic shock admitted to the intensive care unit
Public title
Comparison of the effect of norepinephrine with and without dobutamine on mortality and morbidity of children with septic shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children in the age group of 2 to 14 years
Children with septic shock
They need to transfer to the intensive care unit
Exclusion criteria:
Children with organ failure
The patient's lack of consent, or if the patient is unable to answer, the patient's guardian's lack of consent
The presence of heart failure, kidney and diabetes
Age
From 2 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize people to the two groups, the block randomization method is used in such a way that 4 blocks are used. In each block of 4, 2 people are assigned to the first group and 2 people to the second group. R statistical software is used for random block allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
It is a one-sided blind method, so that the vasopressor is prescribed by the ICU specialist. Cardiac examination (cardiac indices) will be done by a pediatric cardiologist and HR-MAP and urinary tract examination will be done by the senior ICU nurse who does not know the type of vasopressor injection to the patients. Also, laboratory tests will be performed by a technician unaware of the interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee, Kerman University of Medical Sciences
Street address
At the beginning of Jihad Blvd., Research Deputy of Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2022-10-09, 1401/07/17
Ethics committee reference number
IR.KMU.AH.REC.1401.147
Health conditions studied
1
Description of health condition studied
Septic shock
ICD-10 code
T81.12
ICD-10 code description
Postprocedural septic shock
Primary outcomes
1
Description
Hemodynamic and blood supply findings (CO-MAP-HR)
Timepoint
Measuring CO-MAP-HR at the beginning of the study (before the intervention) and then every hour until the end of the study
Method of measurement
Ecocardiography
2
Description
Vasopressor dependence days
Timepoint
The number of days that patients receive vasopressor
Method of measurement
Check list
3
Description
Urinary tract
Timepoint
At the beginning of the study and then every 6 hours until the end of the study
Method of measurement
Check list
4
Description
Duration of hospitalization in the intensive care unit
Timepoint
At the beginning of the study and then daily until the end of hospitalization in the relevant department
Method of measurement
Check list
5
Description
Serum lactate level
Timepoint
At the beginning of the study, then daily until the end of the study
Method of measurement
AutoAnalyzer
6
Description
Electrolytes (urea, creatinine)
Timepoint
At the beginning of the study, then daily until the end of the study
Method of measurement
AutoAnalyzer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The first group receives epinephrine at a dose of 0.1 to 1 mcg/kg in addition to common supportive treatments.
Category
Treatment - Other
2
Description
Intervention group: The second group, in addition to common support treatments, receive epinephrine at a dose of 0.1 to 1 mcg/kg along with 5 mcg/kg of dobutamine.