The effect of selenium in the treatment of acute traumatic brain injury
Phase 2
- Conditions
- acute traumatic brain injury.Intracranial injury
- Registration Number
- IRCT2015090223865N1
- Lead Sponsor
- Vice Chancellor for research of Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 110
Inclusion 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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient functional recovery. Timepoint: The days 30 and 60 after brain injury. Method of measurement: GOS-E(Extended Glasgow Outcome Scale).
- Secondary Outcome Measures
Name Time Method Mortality. Timepoint: The first 24 hours after intensive care unit admission. Method of measurement: Acute Physiology and Chronic Health Evaluation3 score(APACHE3 score).;Level of consciousness. Timepoint: Everyday from the first to 15th day of brain injury. Method of measurement: Full Outline Of UnResponsiveness(FOUR) Score.;Body organ function. Timepoint: Everyday from the first to 15th day of brain injury. Method of measurement: Sequential Organ Failure Assessment(SOFA) Score.;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.;Length of intensive care unit(ICU) stay. Timepoint: Everyday from ICU admission to discharge. Method of measurement: Days number.;Length of hospital stay. Timepoint: Everyday from hospital admission to discharge. Method of measurement: Days number.