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Effects of dexmedetomidine on serum level of inflammatory factors in septic shock ICU patients

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History
# Registration date Revision Id
2 2024-01-23, 1402/11/03 292429
1 2020-05-12, 1399/02/23 134020
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  • Protocol summary

    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.
    Participants will be randomly assigned to two groups of intervention and control with 24 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.
    بیماران به روش balanced block randomization با استفاده از بلوک های تصادفی 4 تایی در دو گروه 33 نفره مداخله و کنترل قرار می گیرند. تصادفی سازی با استفاده از گزینه تصادفی سازی نرم افزار در اکسل انجام خواهد شد. فرایند تصادفی سازی توسط مشاور متدولوژی مطالعه است و محققین بالینی از فرایند تصادفی سازی اطلاع ندارند.
    بیماران به روش balanced block randomization با استفاده از بلوک های تصادفی 4 تایی در دو گروه24 نفره مداخله و کنترل قرار می گیرند. تصادفی سازی با استفاده از گزینه تصادفی سازی نرم افزار در اکسل انجام خواهد شد. فرایند تصادفی سازی توسط مشاور متدولوژی مطالعه است و محققین بالینی از فرایند تصادفی سازی اطلاع ندارند.
    Inclusion criteria: Septic shock over 18 years old Exclusion criteria: Blood pressure controlled by receiving a maximum of 10 norepinephrine Hypovolemia
    Inclusion criteria: Septic shock over 18 years old Exclusion criteria: Receiving 10 micrograms per minute of norepinephrine or higher Heart blocks History of beta-blockers using
    شرایط ورود: بیماران مبتلا به شوک سپتیک بالای 18 سال معیار خروج: فشار خون بیمار با دریافت حداکثر 10 ميكروگرم در دقيقه نوراپى نفرين کنترل باشد هیپوولمی
    شرایط ورود: بیماران مبتلا به شوک سپتیک بالای 18 سال معیار خروج: دریافت 10 ميكروگرم در دقيقه نوراپى نفرين و یا بالاتر بلاک های قلبی سابقه مصرف بتابلاکر

  • General information

    Not used
    Used
    66
    48
    empty
    48
    empty
    2018-08-25, 1397/06/03
    empty
    2019-12-21, 1398/09/30
    empty
    2019-12-21, 1398/09/30
    empty
    Completion of the study
    empty
    اتمام مطالعه
    hypovolemia
    History of beta-blockers using
    Heart block or sick sinus syndrome
    Norepinephrine greater than 10 mcg/kg/min
    هیپوولمی
    سابقه مصرف بتابلاکرها
    بلاک های قلبی
    دریافت نوراپی نفرین با دوز بالاتر از10 mcg/kg/min

  • Primary outcomes

    #1
    سطح خونی فاکتور التهابی اینترلوکین 1
    سطح خونی فاکتور های التهابی اینترلوکین 1
    #2
    سطح خونی فاکتور التهابی اینترلوکین 6
    سطح خونی فاکتور های التهابی اینترلوکین 6
    #3
    Serum level of Inflammatory factor TNF-α
    Serum level of Inflammatory factor TNF-a
    سطح خونی فاکتور التهابی TNF-α
    سطح خونی فاکتور های التهابی TNF-a

  • Secondary outcomes

    #1
    empty
    changing norepinephrine dose of
    empty
    تغییرات دوز نوراپی نفرین
    empty
    Baseline and after 24 hours
    empty
    بدو مطالعه و 24 ساعت بعد
    empty
    Clinical observation
    empty
    مشاهده بالینی
    #2
    empty
    changing in Sofa score
    empty
    تغییرات امتیاز SOFA
    empty
    Baseline and after 24 hours
    empty
    بدو مطالعه و 24 ساعت بعد
    empty
    checklist
    empty
    چک لیست

  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Khomeini Hospital
    Name of recruitment center - Persian: بیمارستان امام خمینی
    Full name of responsible person - English: Mehi Mokhlesian
    Full name of responsible person - Persian: مهدی مخلصیان
    Street address - English: Amir Mzandarani st.
    Street address - Persian: خیابان امیر مازندرانی
    City - English: sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 57148-54367
    Phone: +98 11 3336 1701
    Fax:
    Email: F.heydari@mazums.ac.ir
    Web page address:
    Name of recruitment center - English: Imam Hospital
    Name of recruitment center - Persian: بیمارستان امام ساری
    Full name of responsible person - English: Mehi Mokhlesian
    Full name of responsible person - Persian: مهدی مخلصیان
    Street address - English: Imam Hospital, Amir Mzandarani Blvd.
    Street address - Persian: بلوار امیر مازندرانی، بیمارستان امام
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 5714854367
    Phone: +98 11 3336 1701
    Fax:
    Email: f.heydari@mazums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: fatemeh heydari
    Full name of responsible person - Persian: فاطمه حیدری
    Street address - English: Amir Mazandarani st
    Street address - Persian: خیابان امیرمازندرانی
    City - English: sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 57148-54367
    Phone: +98 11 3336 1701
    Fax:
    Email: f.hydari@mazums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Majid Saeidi, Vice chancellor for research, Mazandaran University of Medical Sciences
    Full name of responsible person - Persian: دکتر مجید سعیدی، معاونت پژوهشی دانشگاه علوم پزشکی مازندران
    Street address - English: Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem square, Sari
    Street address - Persian: ساری، میدان معلم، معاونت پژوهشی دانشگاه علوم پزشکی مازندران
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4817844718
    Phone: +98 11 3336 1701
    Fax:
    Email: majsaeedi@yahoo.com
    Web page address:

Protocol summary

Study aim
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 24 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: Receiving 10 micrograms per minute of norepinephrine or higher Heart blocks History of beta-blockers using
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
Completion of the study
Acronym
IRCT registration information
IRCT registration number: IRCT20181104041551N2
Registration date: 2020-05-12, 1399/02/23
Registration timing: retrospective

Last update: 2024-01-23, 1402/11/03
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
2018-08-25, 1397/06/03
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2019-12-21, 1398/09/30
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:
History of beta-blockers using Heart block or sick sinus syndrome Norepinephrine greater than 10 mcg/kg/min
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 48
Actual sample size reached: 48
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
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
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
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-a
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

2

Description
changing norepinephrine dose of
Timepoint
Baseline and after 24 hours
Method of measurement
Clinical observation

3

Description
changing in Sofa score
Timepoint
Baseline and after 24 hours
Method of measurement
checklist

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 Hospital
Full name of responsible person
Mehi Mokhlesian
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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeidi, Vice chancellor for research, Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3336 1701
Email
majsaeedi@yahoo.com
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
Send email
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