EUCTR2012-003158-10-IE
Active, not recruiting
Phase 1
ADRENAL- ADjunctive coRticosteroid trEatment iN criticAlly ilL patients with septic shock. - ADRENA
DrugsSolu-Cortef
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The George Institute for Global Health
- Enrollment
- 3800
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
- •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.
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.
Outcomes
Primary Outcomes
Not specified
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