Comparison of the effect of intravenous selenium and magnesium sulfate on the clinical outcomes of patients with severe traumatic brain injury in the intensive care unit.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240605062022N1

Enrollment

110

Registered

2024-06-12

Start date

2024-09-21

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Severe traumatic brain injury. Traumatic cerebral edema

Interventions

Intervention 1: Intervention group: Selenium group 500 µg intravenous bolus within 30 minutes and then 500 µg intravenous infusion 24 hours for 14 consecutive days. Intervention 2: Control group: Magn

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients with blunt trauma All patients with a level of consciousness score greater than 3 to 8 referred to Imam Khomeini Hospital in Urmia, and the written consent form to participate in the research project has been signed by the first degree relatives of the patient (father-mother-spouse-child).

Exclusion criteria

Exclusion criteria: People with end stage chronic disease Dialysis patients pregnant women Active gastrointestinal bleeding Post CPR patients Glasgow coma score equal to 3 Pupil without reaction to bilateral light Probability of surviving less than 24 hours Systolic blood pressure less than 90 mmHg for more than 10 minutes Spinal cord injury A known case of kidney, liver and heart failure

Design outcomes

Primary

Measure	Time frame
Adverse consequences (death, vegetative life, severe disability and moderate disability) Desired outcome (good recovery). Timepoint: It will be measured before the intervention and 14 days after the intervention. Method of measurement: GCS scale 5 levels of the main scale are 1-death, 2-vegetative life (lack of spontaneous interaction with the environment), 3-severe disability (has the ability to follow orders but cannot live independently), 4-moderate disability (can live independently but is not able to return to work or school) and 5- good recovery (can work).	—

Measure

Time frame

Adverse consequences (death, vegetative life, severe disability and moderate disability) Desired outcome (good recovery). Timepoint: It will be measured before the intervention and 14 days after the intervention. Method of measurement: GCS scale 5 levels of the main scale are 1-death, 2-vegetative life (lack of spontaneous interaction with the environment), 3-severe disability (has the ability to follow orders but cannot live independently), 4-moderate disability (can live independently but is not able to return to work or school) and 5- good recovery (can work).

—

Secondary

Measure	Time frame
Duration of hospitalization in the ward and ICU. Timepoint: Number of days of hospitalization. Method of measurement: days of hospitalization.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shahriar Sane

Oroumia University of Medical Sciences

shahryarsane@yahoo.com+98 44 3346 9931

Outcome results

None listed

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