Status:
COMPLETED
ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients With Septic Shock
Lead Sponsor:
The George Institute
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Australian and New Zealand Intensive Care Society Clinical Trials Group
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to find out whether adult patients admitted to the Intensive Care Unit with septic shock who are given hydrocortisone compared to placebo (a dummy solution), will have an ...
Detailed Description
Primary Objective To evaluate the impact of intravenous hydrocortisone versus placebo on all cause mortality at 90 days in critically ill patients with septic shock. The hypothesis is that hydrocortis...
Eligibility Criteria
Inclusion
- Aged 18 years or older
- Documented site of infection, or strong suspicion of infection, with 2 of the 4 clinical signs of inflammation:
- Core temperature \> 38°C or \< 35°C
- Heart rate \> 90 beats per minute
- White cell count \> 12 x 109/L or \< 4 x 109/L or \> 10% immature neutrophils
- Respiratory rate \> 20 breaths per minute, or PaCO2 \< 32 mmHg, or mechanical ventilation.
- Being treated with mechanical ventilation at the time of randomisation
- 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
- Administration of vasopressors or inotropes for = 4 hours and present at time of randomisation.
Exclusion
- Met all inclusion criteria more than 24 hours ago
- Clinician expects to prescribe systemic corticosteroids for an indication other than septic shock (not including nebulised or inhaled corticosteroid)
- Patients treated with etomidate
- Patients receiving treatment with Amphotericin B for systemic fungal infections at time of randomisation
- Patients with documented cerebral malaria at the time of randomisation
- Patients with documented strongyloides infection at the time of randomisation
- 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
- Death from underlying disease is likely within 90 days
- Patient has been previously enrolled in the ADRENAL study.
Key Trial Info
Start Date :
June 13 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2017
Estimated Enrollment :
3800 Patients enrolled
Trial Details
Trial ID
NCT01448109
Start Date
June 13 2012
End Date
November 20 2017
Last Update
December 12 2017
Active Locations (70)
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1
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
3
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
4
Gosford Hospital
Gosford, New South Wales, Australia, 2250