Assessment of the simvastatin effect on the outcome of patients with brain injuries in ICU

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201305075363N3

Enrollment

Registered

2013-09-21

Start date

2013-05-01

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

brain injuries. Traumatic cerebral oedema, Diffuse brain injury,Focal brain injury,Epidural haemorrhage, Traumatic subdural haemorrhage, Traumatic subarachnoid haemorrhage, Intracranial injury with prolonged coma, Other intracranial injuries, Intracranial injury, unspec

Interventions

Intervention 1: Group 2 (control) will be administered placebo tablet Contains lactolos until the patients are admitted in the ICU. Intervention 2: Group 1 (S) will be administered 80 mg of simvastati

Treatment - Drugs

Group 2 (control) will be administered placebo tablet Contains lactolos until the patients are admitted in the ICU

Group 1 (S) will be administered 80 mg of simvastatin at the first day which followed by 40 mg up until the patients are admitted in ICU

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: APACHEE score less than 35, age between 18 and 60 years old, patients with brain injuries that scheduled to ICU admission Exclusion criteria:Receiving NSAIDS or corticosteroids, known hypersensitivity to the study drugs, history of cardiac, respiratory, neuromuscular, hepatic or renal diseases, history of brain injuries and pregnancy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
CRP. Timepoint: first day , 72 h after brain injury. Method of measurement: Kit.;IL6. Timepoint: first day , 72 h after brain injury. Method of measurement: ELISA Kit.;The number of admission days in the ICU. Timepoint: The last day of admission in the ICU. Method of measurement: Observation.;Patient GCS at the first day of admission in the ICU. Timepoint: The first day of admission. Method of measurement: Physical examination.;Patient GCS at discharge from the ICU. Timepoint: The last day of admission. Method of measurement: Physical examination.;Time of connecting the patient to the ventilator. Timepoint: Time in which the patient is connected to the ventilator. Method of measurement: observation.	—

Measure

Time frame

CRP. Timepoint: first day , 72 h after brain injury. Method of measurement: Kit.;IL6. Timepoint: first day , 72 h after brain injury. Method of measurement: ELISA Kit.;The number of admission days in the ICU. Timepoint: The last day of admission in the ICU. Method of measurement: Observation.;Patient GCS at the first day of admission in the ICU. Timepoint: The first day of admission. Method of measurement: Physical examination.;Patient GCS at discharge from the ICU. Timepoint: The last day of admission. Method of measurement: Physical examination.;Time of connecting the patient to the ventilator. Timepoint: Time in which the patient is connected to the ventilator. Method of measurement: observation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Sara Madani

Zanjan University of Medical Sciences

Dr_s_madani@yahoo.com+98 911 142 0004

Outcome results

None listed

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