None listed
Conditions
Interventions
Drug :
Eligible and consenting participants will be randomized to receive steroid or matching placebo solutions in a 1:1 ratio, without stratification and using a block size of 4, by means of a compu
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years and = 80 years 2. Acute traumatic brain injury [epidural hematoma (EDH), subdural hematoma (SDH), subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), intraventricular hemorrhage (IVH) and etc.], nontraumatic brain hemorrhage such as aneurysmal SAH, or ICH/IVH due to hypertensive, cerebral amyloid angiopathy, arteriovenous fistula (AVF), arteriovenous malformation (AVM), cavernous malformation (CM) and etc. 3. Underwent brain hemorrhage surgery [craniotomy and hematoma evacuation, decompressive craniectomy, extra ventricular drainage (EVD), burr hole trephination and etc.] within 48hours of hospital admission. 4. Glasgow coma score (GCS) on randomization: 5-13 5. Expected ICU stay > 72 hours
Exclusion criteria
Exclusion criteria: 1. Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative) 2. Known previous neurological disease, causing significant cognitive and/or motor strength deficit 3. Brain tumor (benign or malignant) bleeding 4. Previous medical history of adrenal insufficiency within previous 6 months 5. Current or history of (within 6 months) steroid administration due to underlying disease such as cardiac or pulmonary disease (transplantation, heart failure, interstitial lung disease, asthma, etc.), inflammatory disease (rheumatoid disease, lupus nephritis, etc.), dermatology disease (psoriasis, eczema, drug rash and etc.), spinal disease (spinal cord injury, degenerative disease), etc. 6. History of brain hemorrhage within 2 years. 7. Diagnosis of hematologic disease results in brain hemorrhage [acute myeloid leukemia, acute lymphocytic leukemia, or other disease-causing thrombocytopenia (2)]. 8. Current or history (within 3 months) of administrating antiplatelets (aspirin, clopidogrel or cilostazole) or anticoagulation (heparin or low-molecular weight heparin, vitamin K antagonist (warfarin) or direct oral anticoagulants) 9. Liver cirrhosis – Child’s class C liver disease 10. Pregnancy 11. Status epilepticus or seizure disorder requiring anticonvulsant medication 12. GCS of 3 with both fixed and dilated pupils; Brain death or imminent death (within 24 hours) 13. Patients with a DNR (do not resuscitate) order 14. Multiple trauma (2 or more concurrent traumatic injuries) 15. Prior exposure to etomidate 16. Laboratory evidence of acute infection 17. Confirmed diagnosis with end-stage malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study evaluates the significance of Critically Ill-Related Corticosteroid Insufficiency (CIRCI) in neuro-critical care patients with acute brain injury and assesses their survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of Critically Ill Related Corticosteroid Insufficiency (CIRCI) in the postoperative acute brain injury patients;Serum biomarkers concentration;Neurologic outcome using dichotomized mRS;Need for tracheostomy;Duration of mechanical ventilation (days);Duration of vasoactive drugs administered (days);The incidence of postoperative pneumonia;Length of hospital and ICU stay (days);Time to reach target sedation level (Richmond Agitation Sedation Scale target: -2~0);Metabolic intolerance (hyper/hypo-glycemia, hyper/hypo-natremia, hyper/hypo-kalemia);Serious adverse events(SAE) occurrence | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunchul Jung
Asan Medical Center
Outcome results
None listed