KCT0012389进行中（未招募）3 期
A Multicenter, Prospective, Randomized, Single-Blind Clinical Trial to Evaluate Biomarker-Based Diagnosis of Critical Illness–Related Corticosteroid Insufficiency (CIRCI) and the Efficacy of Hydrocortisone Replacement Therapy in Patients with Severe Neurosurgical Condition (Blood biomarkEr-guided Adrenal COrtisol replacement in Neurocritical illness; BEACON study)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 356
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •Age =18 years and = 80 years
- •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.
- •Underwent brain hemorrhage surgery [craniotomy and hematoma evacuation, decompressive craniectomy, extra ventricular drainage (EVD), burr hole trephination and etc.] within 48hours of hospital admission.
- •Glasgow coma score (GCS) on randomization: 5-13
- •Expected ICU stay > 72 hours
排除标准
- •Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative)
- •Known previous neurological disease, causing significant cognitive and/or motor strength deficit
- •Brain tumor (benign or malignant) bleeding
- •Previous medical history of adrenal insufficiency within previous 6 months
- •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.
- •History of brain hemorrhage within 2 years.
- •Diagnosis of hematologic disease results in brain hemorrhage [acute myeloid leukemia, acute lymphocytic leukemia, or other disease-causing thrombocytopenia (< 50x10³/uL) or coagulopathy (INR >2)].
- •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)
- •Liver cirrhosis – Child’s class C liver disease
- •Status epilepticus or seizure disorder requiring anticonvulsant medication
- •GCS of 3 with both fixed and dilated pupils; Brain death or imminent death (within 24 hours)
- •Patients with a DNR (do not resuscitate) order
- •Multiple trauma (2 or more concurrent traumatic injuries)
- •Prior exposure to etomidate
- •Laboratory evidence of acute infection
- •Confirmed diagnosis with end-stage malignancy
研究者
相似试验
进行中（未招募）
不适用
A prospective, randomized, controlled, multicenter study to evaluate the efficacy and safety of the designated Digital Application "OsteoCoach" for fall prevention, fracture prevention and enhanced mobility in older adults with osteoporosisOsteoporosis (ICD-10-GM M80.– Osteoporosis with pathological fractureM81.– Osteoporosis without pathological fracture). Fall and fracture prevention, functional mobility, muscle strength of the lower extremities.M80M81Osteoporosis with pathological fractureOsteoporosis without pathological fractureDRKS00041144Osteoconnect GmbH182
招募中
不适用
A Clinical Study to Evaluate the Efficacy and Safety of Pulmonary Rehabilitation Software EB-S100 in Patients with Chronic Obstructive Pulmonary DiseaseDiseases of the respiratory systemKCT0012275Emocog Co., Ltd.64
招募中
不适用
A Phase III Study of M610101 in Patients with Atopic DermatitisAtopic dermatitisjRCT2031260244150
尚未招募
不适用
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's DiseaseAlzheimer's DiseasejRCT20312603661,600
招募中
不适用
A Prospective Comparative Study Evaluating the Effectiveness of a Novel Endoscopic Resection Technique (Tip-in UEMR) for Superficial Duodenal Tumors Measuring 10-20 mmSuperficial non-ampullary duodenal epithelial tumor (SNADET)jRCT105225018376