The effect of dexmedetomidine on the blood level of inflammatory markers in patients with septic shock
Design
Participants will be randomly assigned to two groups of intervention and control with 33 members using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process.
Settings and conduct
The intervention group, will receive a dose of 0.6 µg/kg/h dexmedetomidine for 12 hours.The dexmedetomidine vials contain 100 mcg of medicine which should be diluted and will reach the concentration of 4 mic/mL. Normal saline infusion of 6 ml/kg/h is infused in the control group instead of dexmedetomidine for 12 hours.
The present study is double-blind so that patients and the final evaluator will be unaware of how the intervention and control group is allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Septic shock over 18 years old
Exclusion criteria:
Blood pressure controlled by receiving a maximum of 10 norepinephrine
Hypovolemia
Intervention groups
The Intervention group receives Dexmedetomidine vial made by Hospira Co. with the brand name of Precedex, with a dose of 1 µg/kg for 10 minutes and then 0.2-2.5 µg/kg/h for 24 hours.The control group receives intravenous morphine manufactured by Darosh Pakhsh Co. with a dose of 0.5 to 5 mg/h and Midazolam intravenously from Daroo Pakhsh Co. with a dose of 0.5 to 5 mg/h
Main outcome variables
Main outcome variables include inflammatory factors including interleukin 1, interleukin 6, alpha TNF, the sedative effects of dexmedetomidine based on Richmond agitation-sedation scale, the study of changes in norepinephrine dose in two groups and the side effects of dexmedetomidine administration.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181104041551N2
Registration date:2020-05-12, 1399/02/23
Registration timing:retrospective
Last update:2020-05-12, 1399/02/23
Update count:1
Registration date
2020-05-12, 1399/02/23
Registrant information
Name
Fateme Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
f.heydari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of dexmedetomidine on serum level of inflammatory factors in septic shock ICU patients
Public title
Effects of dexmedetomidine on septic shock ICU patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with septic shock over 18 years old
Exclusion criteria:
hypovolemia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control with 33 members using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process.
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting the samples, none of the participant will be aware of randomization and allocation to groups. The data analyzer is from out of the study and all data will be provided in the form of coding to him. So, the present study is double-blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Amir Mazandarani st.Imam Khomeini hospital
City
sari
Province
Mazandaran
Postal code
57148-54367
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.101
Health conditions studied
1
Description of health condition studied
Septic shock
ICD-10 code
R65.21
ICD-10 code description
Severe sepsis with septic shock
Primary outcomes
1
Description
Serum level of Inflammatory factor IL-1
Timepoint
Before the use of dexmedetomidine and after 24 hours
Method of measurement
ELISA test
2
Description
Serum level of Inflammatory factor IL-6
Timepoint
Before the use of dexmedetomidine and after 24 hours
Method of measurement
ELISA test
3
Description
Serum level of Inflammatory factor TNF-α
Timepoint
Before the use of dexmedetomidine and after 24 hours
Method of measurement
ELISA test
Secondary outcomes
1
Description
Investigation of the sedative effects of dexmedetomidine
Timepoint
Baseline and after 24 hours
Method of measurement
Richmond agitation-sedation scale
Intervention groups
1
Description
The Intervention group receives Dexmedetomidine vial made by Hospira Co. with the brand name of Precedex, with a dose of 1 µg/kg for 10 minutes and then 0.2-2.5 µg/kg/h for 24 hours.
Category
Treatment - Drugs
2
Description
Control group: The control group receives intravenous morphine manufactured by Darosh Pakhsh Co. with a dose of 0.5 to 5 mg/h and Midazolam intravenously from Daroo Pakhsh Co. with a dose of 0.5 to 5 mg/h
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mehi Mokhlesian
Street address
Amir Mzandarani st.
City
sari
Province
Mazandaran
Postal code
57148-54367
Phone
+98 11 3336 1701
Email
F.heydari@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
fatemeh heydari
Street address
Amir Mazandarani st
City
sari
Province
Mazandaran
Postal code
57148-54367
Phone
+98 11 3336 1701
Email
f.hydari@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Heydari
Position
Assistant Professo
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hospital, Amir Mzandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
5714854367
Phone
+98 11 3336 1701
Email
f.heydari@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Heydari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hospital, Amir Mzandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
5714854397
Phone
+98 11 3335 0672
Email
f.heydari@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Heydari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hospital, Amir Mzandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
5714854367
Phone
+98 11 3335 0672
Email
f.heydari@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
Starting from April 2020
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Everyone
From where data/document is obtainable
Email to f.heydari@mazums.ac.ir
What processes are involved for a request to access data/document