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

The Value of Post-Operative Critical Illness Related Corticosteroid Insufficiency (CIRCI) in Adult Neurosurgery (HYdrocortisone theraPy in nEurocRitical illness; HYPER study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004425

Enrollment

240

Registered

2019-11-05

Start date

2019-10-30

Completion date

Unknown

Last updated

2023-04-04

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

Conditions

None listed

Interventions

Drug : Drug: Hydrocortisone Drug name: Solucortef Dosage: 100mg (8am), 50mg (7pm) Times of administration: 2 times /day Duration: 7 days Administration site: via central or peripheral line

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Glasgow Coma Scale, Modified Rankin Scale	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactMoinay Kim

University of Ulsan

aussie84@naver.com+82-2-3010-3550

Outcome results