Critically Illness - Related Corticosteroid Insufficiency (CIRCI) in the Postoperative Acute Brain Hemorrhage Patients: A Prospective, Multicenter, Randomized, Blind Study

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0004425

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1.Age =18 years and = 80 years
2.Acute hemorrhagic stroke (non-trauma); subarachnoid hemorrhage (SAH) d/t aneurysm rupture, arterio-venous malformation (AVM) or cavernous malformation (CM) rupture, (hypertensive) intracranial or intraventricular hemorrhage (ICH or IVH), subdural or epidural hematoma (SDH or EDH) or cerebral infarct
3.Underwent neurosurgery (general anesthesia): decompressive craniectomy, hematoma evacuation, AVM or CM resection, (either primary or anticoagulants-associated)
4.Glasgow Coma Score (GCS): 5-13
5.Expected ICU stay > 72 hours

Exclusion Criteria

1.Hemorrhagic stroke due to trauma
2.Hemorrhagic stroke but non-operative cases
3.Hemorrhagic stroke due to thrombocytopenic or coagulopathy
4.Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative)
5.Known previous neurological disease, causing significant cognitive and/or motor handicap
6.Hemorrhagic stroke due to brain tumor
7.Brain death or imminent death (within 24 hours)
8.Pregnancy or Nephrotic syndrome diagnosed patient
9.Recent ACTH deficiency (pituitary surgery, pituitary stalk trauma)
10.Previous history of adrenal insufficiency, previous immunosuppression, treatment with corticosteroids with the last 6 months
11.DNR (do not resuscitate) orders

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glasgow Coma Scale, Modified Rankin Scale

Secondary Outcome Measures

Name	Time	Method
Duration of intensive care unit stay;Time to RASS target (target: -2 - 0);Need for tracheostomy;Use of vasoactive drugs (days): Norepinephrine, Epinephrine, Dobutamine, Vasopressin and etc