EUCTR2012-003158-10-DK进行中（未招募）1 期
ADRENAL- ADjunctive coRticosteroid trEatment iN criticAlly ilL patients with septic shock. - ADRENA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years or older
- •2. Documented site of infection, or strong suspicion of infection
- •3. 2 of the 4 clinical signs of inflammation:
- •a. Core temperature > 38oC or < 36oC
- •b. Heart rate > 90 beats per minute
- •c. Respiratory rate > 20 breaths per minute, or PaCO2 < 32 mmHg, or mechanical ventilation.
- •d. White cell count > 12 x 109/L or < 4 x 109/L or > 10% immature neutrophils
- •4. Being treated with mechanical ventilation at the time of randomisation (includes BiPAP or CPAP)
- •5. Being treated with continuous vasopressors or inotropes to maintain a systolic blood pressure > 90mmHg, or mean arterial blood pressure > 60mmHg, or a MAP target set by the treating clinician for maintaining perfusion
- •6. Administration of vasopressors or inotropes for = 4 hours and present at time of randomisation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Met all inclusion criteria more than 24 hours ago
- •2. Clinician expects to prescribe systemic corticosteroids for an indication other than septic shock (not including nebulised or inhaled corticosteroid)
- •3. Patients treated with etomidate
- •4. Patients receiving treatment with Amphotericin B for systemic fungal infections at time of randomisation
- •5. Patients with documented cerebral malaria at the time of randomisation
- •6. Patients with documented strongyloides infection at the time of randomisation
- •7. Death is deemed inevitable or imminent during this admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment
- •8. Death from underlying disease is likely within 90 days
- •9. Patient has been previously enrolled in the ADRENAL study.
研究者
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