Status:
UNKNOWN
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
Lead Sponsor:
Belinda Howe
Collaborating Sponsors:
Australian and New Zealand Intensive Care Society Clinical Trials Group
Australasian College for Emergency Medicine
Conditions:
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The ARISE RCT is a multi-centre, randomised, controlled trial of EGDT compared to standard care in patients with severe sepsis presenting to the ED. The study will be conducted in multiple sites with ...
Detailed Description
The primary aim of the study is to determine whether providing EGDT, compared to standard care, reduces 90-day mortality in patients presenting to the ED of hospitals in Australasia with severe sepsis...
Eligibility Criteria
Inclusion
- Suspected or confirmed infection
- The presence of TWO or MORE of the following SIRS criteria:
- Core temperature \< 36.0 degC or \> 38.0 degC
- Heart rate \> 90 beats/minute
- Respiratory rate \> 20 breaths/minute or PaCO2 \< 32 mmHg or the requirement for mechanical ventilation for an acute process
- White blood cell count \> 12.0 or \< 4.0 x109/L or \> 10% immature band forms
- Evidence of either refractory hypotension OR hypoperfusion:
- Refractory hypotension is confirmed by the presence of a systolic blood pressure (SBP) \< 90 mmHg or mean arterial pressure (MAP) \< 65 mmHg after a 1000ml intravenous (IV) fluid challenge within 60 minutes (including IV fluids administered pre-hospital)
- Hypoperfusion is confirmed by the presence of a blood lactate concentration greater than or equal to 4.0 mmol/L
- First dose of IV antimicrobial therapy commenced prior to randomisation
Exclusion
- Age \< 18 years
- Contra-indication to superior vena cava (SVC) CVC insertion
- Contra-indication to blood products (e.g. Jehovah's Witness)
- Inability to commence delivery of the EGDT protocol within 1 hour of randomisation or complete 6 hours of EGDT
- Haemodynamic instability due to active bleeding
- Pregnancy (confirmed or suspected)
- In-patient transfer from another acute health care facility
- An underlying disease process with a life expectancy of \< 90 days
- Death is deemed imminent and inevitable
- A "limitation of therapy" order has been documented restricting implementation of the study protocol or the treating clinician deems aggressive care unsuitable
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2015
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT00975793
Start Date
October 1 2008
End Date
April 1 2015
Last Update
April 24 2014
Active Locations (51)
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1
Canberra Hospital
Garran, Australian Capital Territory, Australia
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
3
Coffs Harbour Hospital
Coffs Harbour, New South Wales, Australia
4
St Vincent's Hospital (Sydney)
Darlinghurst, New South Wales, Australia