A multi-centre, blinded, randomised, placebo controlled trial to determine whether hydrocortisone therapy reduces 90-day mortality in patients admitted to intensive Care with septic shock.

The George Institute for Global Health0 个研究点目标入组 3,800 人开始时间: 2011年10月5日最近更新: 2020年1月13日

适应症

试验速览

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•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: i. Core temperature > 38 degrees C or < 35 degrees C ii. Heart rate > 90 beats per minute iii. White cell count > 12 x 109/L or < 4 x 109/L or > 10% immature neutrophils iv. Respiratory rate > 20 breaths per minute, or PaCO2 < 32 mmHg, or mechanical ventilation. 4. Being treated with mechanical ventilation at the time of randomisation 5. Being treated with 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 greater than or equal to 4 hours and present at time of randomisation.

•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.

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