The effect of selenium in the treatment of acute traumatic brain injury

The study of intravenous selenium effect in the outcome of patients with acute traumatic brain injury

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015090223865N1

Enrollment

110

Registered

2016-01-14

Start date

2015-08-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute traumatic brain injury. Intracranial injury

Interventions

Intervention 1: 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. Intervention 2: sodium chloride 0.9

Treatment - Drugs

Placebo

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

sodium chloride 0.9% in the same regimen

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Patient functional recovery. Timepoint: The days 30 and 60 after brain injury. Method of measurement: GOS-E(Extended Glasgow Outcome Scale).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShakiba Mozari

Iran University of Medical Sciences

"Mozarish@medsab.ac.ir"; "sh.mozari@gmail.com"+98 21 86701

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026