Abstract
AIM: The present study was carried out to examine this hypothesis that administration of selenium can prevent the development of injuries by brain trauma and thus can modulate patients' functional recovery and also improve posttraumatic outcome. MATERIALS AND METHODS: This double-blinded controlled trial was carried out on 113 patients who were hospitalized following traumatic brain injury (TBI) with Glasgow Coma Scale score of 4-12 that were randomly assigned to receive selenium within 8 h after injury plus standard treatment group or routine standard treatment alone as the control. The primary endpoint was to assess patients' functional recovery at 2 months after the injury based on extended Glasgow Outcome Scale score (GOS-E). Secondary outcomes included the changes in Full Outline of Unresponsiveness score (FOUR) score, Sequential Organ Failure Assessment (SOFA) score, and acute physiology and chronic health evaluation (APACHE) III score, side effects of selenium, length of Intensive Care Unit (ICU) stay, and length of hospital stay. RESULTS: There was no difference in the length of ICU and hospital stay, the trend of the change in FOUR and SOFA scores within 15 days of first interventions, and the mean APACHE III score on the 1(st) and 15(th) days between the two groups. Mortality was 15.8% in selenium group and 19.6% in control group with no between-group difference. No difference was revealed between the two groups in appropriate outcome according to GOS-E score at 60 ± 10 days and also 30 ± 5 days according to the severity of TBI. CONCLUSION: This human trial study could not demonstrate beneficial effects of intravenous infusion of selenium in the improvement of outcomes in patients with acute TBI.