The aim of this investigation is whether the selenium has efficacy on functional recovery of patients with acute traumatic brain injury(TBI) or not.
This study is a prospective, double-blind, unicenteric, phase 2 clinical trial. A total of 110 patients, 18 to 100 years of age, with moderate and severe acute traumatic brain injury (Glasgow Coma Scale score of ≤ 12) and at least one reactive pupil are randomly assigned to take daily selenium or placebo intravenous infusion in addition to standard treatment of TBI. The study treatment is initiated within the first 8 hours after brain injury and is continuing for the consecutive 14 days.
The primary outcome is the patient functional recovery according to Extended Glasgow Outcome Scale (GOS-E), determined in the days 30 and 60 after brain injury. The secondary outcomes include mortality, level of consciousness, body organs function, selenium side effects, length of intensive care unit(ICU) stay and length of hospital stay.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090223865N1
Registration date:2016-01-14, 1394/10/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-14, 1394/10/24
Registrant information
Name
Shakiba Mozari
Name of organization / entity
Sabzevar University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 4466 8481
Email address
mozarish@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of intravenous selenium effect in the outcome of patients with acute traumatic brain injury
Public title
The effect of selenium in the treatment of acute traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: moderate and severe traumatic brain injury according to Glasgow Coma Scale score 12 or less; 18 to 100 years of age; at least one reactive pupil; selenium initiated within 8 hours after brain injury.
Exclusion criteria: Glasgow Coma Scale score 3; bilaterally fixed pupils; hypotension (systolic BP<90 mmHg for≥10 min); a life expectancy of less than 24 hours; spinal cord injury; pregnancy; only an isolated epidural hematoma; known case of renal failure.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomization based on the right number of national code(odd or even)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences; Hemmat Highway
City
Tehran
Postal code
Approval date
2015-08-09, 1394/05/18
Ethics committee reference number
IR.IUMS.rec.1394.9311692002
Health conditions studied
1
Description of health condition studied
acute traumatic brain injury
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
Patient functional recovery
Timepoint
The days 30 and 60 after brain injury
Method of measurement
GOS-E(Extended Glasgow Outcome Scale)
Secondary outcomes
1
Description
Mortality
Timepoint
The first 24 hours after intensive care unit admission
Method of measurement
Acute Physiology and Chronic Health Evaluation3 score(APACHE3 score)
2
Description
Level of consciousness
Timepoint
Everyday from the first to 15th day of brain injury
Method of measurement
Full Outline Of UnResponsiveness(FOUR) Score
3
Description
Body organ function
Timepoint
Everyday from the first to 15th day of brain injury
Method of measurement
Sequential Organ Failure Assessment(SOFA) Score
4
Description
Selenium side effects(nausea, vomiting, nail changes, hair loss, tremor, garlic odor, flushing)
Timepoint
Everyday from the first to 15th day of brain injury
Method of measurement
Clinical exam
5
Description
Length of intensive care unit(ICU) stay
Timepoint
Everyday from ICU admission to discharge
Method of measurement
Days number
6
Description
Length of hospital stay
Timepoint
Everyday from hospital admission to discharge
Method of measurement
Days number
Intervention groups
1
Description
A total dose of 500μg intravenous(IV) selenium as a 30-min bolus injection followed by 500μg as a 24 hours IV infusion for the consecutive 14 days
Category
Treatment - Drugs
2
Description
sodium chloride 0.9% in the same regimen
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Medical Complex
Full name of responsible person
Shakiba Mozari
Street address
Hazrat Rasoul Medical Complex, Niyayesh Street, Sattarkhan Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Javad Moosavi
Street address
5th floor, Central Building, Iran University Of Medical Science, Hemmat Highway
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shakiba Mozari
Position
Intensive Care Fellowship
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 86701
Fax
Email
"Mozarish@medsab.ac.ir"; "sh.mozari@gmail.com"
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shakiba Mozari
Position
Intensive Care Fellowship
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 86701
Fax
Email
"Mozarish.medsab.ac.ir"; "sh.mozari@gmail.com"
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shakiba Mozari
Position
Intensive Care Fellowship
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 86701
Fax
Email
"Mozarish@medsab.ac.ir"; "sh.mozari@gmail.com"
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)