Comparison of the effects of dopamine and dobutamine on children with hypotension admitted to the intensive care unit.
Design
This clinical trial has three parallel groups in phase 2-3 which were performed on 81 randomly selected patients. In group 1, dopamine at a dose of 10 min μgr / kg, in the second group, dobutamine at a dose of 10 min μgr / kg, and in the third group, a combination of these two drugs was used.
Settings and conduct
In this clinical trial, 81 children with hypotension admitted to the NICU and PICU intensive care units of Amirkabir and Taleghani hospitals in Arak in 1398 were randomly divided into three groups. In the first group dopamine at a dose of 10 minutes / kg micrograms and in the second group dobutamine at a dose of 10 kg / kg / micrograms and in the third group a combination of these two drugs was used. The recorded results before and after treatment with dopamine and dobutamine were compared and statistically analyzed.
Participants/Inclusion and exclusion criteria
All children under 15 with hypotension without any underlying disease including malignancies and other chronic diseases
Intervention groups
In this study, 81 children who meet the inclusion criteria are selected. The inclusion criteria for this assessment include patients under the age of 15 who are hospitalized in the intensive care unit and their parents are willing to participate in the study. After obtaining their informed consent, the patients enter the study. Patients are randomly assigned to three categories: 27 children in the dopamine group, 27 children in the dobutamine group, and 27 children in the dopamine + dobotamine group.
Main outcome variables
Hypotension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210116050051N1
Registration date:2021-09-25, 1400/07/03
Registration timing:retrospective
Last update:2021-09-25, 1400/07/03
Update count:0
Registration date
2021-09-25, 1400/07/03
Registrant information
Name
Naser kashefi sis
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4242 2457
Email address
dr.kashefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2018-12-20, 1397/09/29
Actual recruitment start date
2018-05-20, 1397/02/30
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-12-22, 1398/10/01
Scientific title
Comparison of the effects of dopamine and dobutamine on children with hypotension admitted to the intensive care unit.
Public title
Comparison of the effects of dopamine and dobutamine on children with hypotension admitted to the intensive care unit.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children under 15 with hypotension without any other underlying disease
Exclusion criteria:
Children over 15 years
Children with underlying disease
Children with malignancies
Age
From 1 month old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
81
Actual sample size reached:
81
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Amirkabir Hospital
City
arak
Province
Markazi
Postal code
3819693345
Approval date
2020-01-30, 1398/11/10
Ethics committee reference number
IR.ARAKMU.REC.1398.256
Health conditions studied
1
Description of health condition studied
Hypotension
ICD-10 code
I95
ICD-10 code description
Hypotension
Primary outcomes
1
Description
Blood pressure measurement in children using monitoring
Timepoint
It is recorded 24 hours a day, using monitoring during the hospital stay
Method of measurement
monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: Dopamine at a dose of 10 kg / dose μgr daily during hospitalization until appropriate blood pressure is reached
Category
Treatment - Other
2
Description
Group 2 : dobutamine with a dose of 10kg / dose μgr daily during hospitalization until appropriate blood pressure is reached
Category
Treatment - Drugs
3
Description
Group 3: combination of dobutamine with a dose of 10 kg / dose μgr and dopamine with a dose of 10 kg / dose μgr daily during hospitalization until appropriate blood pressure is reached
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive care unit of Amirkabir Hospital in Arak
Full name of responsible person
Nasser Kashefi Sis
Street address
Amirkabir Hospital, Arak
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 41 4242 2457
Email
Dr.kashefi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nasser Kashefi Sis
Street address
Amirkabir Hospital, Arak
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 41 4242 2457
Email
Dr.kashefi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Nasser Kashefi Sis
Position
pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Hospital, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 41 4242 2457
Email
Dr.kashefi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nasser Kashefi Sis
Position
pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Amir Kabir Hospital, Arak
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 41 4242 2457
Email
Dr.kashefi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nasser Kashefi Sis
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Amir Kabir Hospital, Arak
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 41 4242 2457
Email
Dr.kashefi@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
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
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
Title and more details about the data/document
All data can be shared after people are not identified
When the data will become available and for how long
Access period starts from 2020
To whom data/document is available
Researchers working in academic centers
Under which criteria data/document could be used
Data analysis is allowed in order to publish scientific texts by mentioning the source.
From where data/document is obtainable
dr.kashefi@gmail.com - dr.Kashefi Naser sis
What processes are involved for a request to access data/document