Protocol summary
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Study aim
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The effect of dexmedetomidine on the blood level of inflammatory markers in patients with septic shock
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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Completion of the study
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Acronym
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IRCT registration information
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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
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Registration date
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2020-05-12, 1399/02/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-23, 1397/06/01
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Expected recruitment end date
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2019-11-11, 1398/08/20
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Actual recruitment start date
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2018-08-25, 1397/06/03
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Actual recruitment end date
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2019-12-21, 1398/09/30
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Trial completion date
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2019-12-21, 1398/09/30
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Scientific title
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Effects of dexmedetomidine on serum level of inflammatory factors in septic shock ICU patients
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Public title
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Effects of dexmedetomidine on septic shock ICU patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
48
Actual sample size reached:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-02-20, 1397/12/01
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Ethics committee reference number
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IR.MAZUMS.IMAMHOSPITAL.REC.1397.101
Health conditions studied
1
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Description of health condition studied
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Septic shock
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ICD-10 code
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R65.21
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ICD-10 code description
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Severe sepsis with septic shock
Primary outcomes
1
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Description
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Serum level of Inflammatory factor IL-1
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Timepoint
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Before the use of dexmedetomidine and after 24 hours
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Method of measurement
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ELISA test
2
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Description
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Serum level of Inflammatory factor IL-6
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Timepoint
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Before the use of dexmedetomidine and after 24 hours
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Method of measurement
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ELISA test
3
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Description
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Serum level of Inflammatory factor TNF-a
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Timepoint
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Before the use of dexmedetomidine and after 24 hours
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Method of measurement
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ELISA test
Secondary outcomes
1
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Description
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Investigation of the sedative effects of dexmedetomidine
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Timepoint
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Baseline and after 24 hours
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Method of measurement
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Richmond agitation-sedation scale
2
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Description
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changing norepinephrine dose of
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Timepoint
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Baseline and after 24 hours
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Method of measurement
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Clinical observation
3
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Description
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changing in Sofa score
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Timepoint
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Baseline and after 24 hours
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Method of measurement
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checklist
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All data can be shared
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When the data will become available and for how long
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Starting from April 2020
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To whom data/document is available
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People working in academic institutions
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Under which criteria data/document could be used
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Everyone
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From where data/document is obtainable
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Email to f.heydari@mazums.ac.ir
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What processes are involved for a request to access data/document
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Send email
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Comments
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