A randomised blinded placebo controlled trial of hydrocortisone in critically ill patients with septic shock.

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 3800

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality at 90 days after randomisation[90 days after randomisation]

Secondary Outcome Measures

Name	Time	Method

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