Severe Sepsis Clinical Trial
— ARISEOfficial title:
A Multi-centre, Randomised Controlled Trial of Early Goal-directed Therapy in Patients Presenting to the Emergency Department With Severe Sepsis in Australasia
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 1600 patients enrolled into the study.
Hypothesis to be tested: EGDT, compared to standard Australasian resuscitation practice,
reduces 90-day all-cause mortality in patients presenting to the ED with severe sepsis.
Status | Active, not recruiting |
Enrollment | 1600 |
Est. completion date | April 2015 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | The Queen Elizabeth Hospital | Adelaide | South Australia |
Australia | Bendigo Hospital | Bendigo | Victoria |
Australia | Blacktown Hospital | Blacktown | Victoria |
Australia | Box Hill Hospital | Box Hill | Victoria |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | Monash Medical Centre | Clayton | Victoria |
Australia | Coffs Harbour Hospital | Coffs Harbour | New South Wales |
Australia | Dandenong Hospital | Dandenong | Victoria |
Australia | St Vincent's Hospital (Sydney) | Darlinghurst | New South Wales |
Australia | Townsville Hospital | Douglas | Queensland |
Australia | Lyell McEwin Hospital | Elizabeth Vale | South Australia |
Australia | St Vincent's Hospital (Melbourne) | Fitzroy | Victoria |
Australia | Western Hospital | Footscray | Victoria |
Australia | Frankston Hospital | Frankston | Victoria |
Australia | Canberra Hospital | Garran | Australian Capital Territory |
Australia | Geelong Hospital | Geelong | Victoria |
Australia | Gosford Hospital | Gosford | New South Wales |
Australia | Royal Brisbane and Women's Hospital | Herston Brisbane | Queensland |
Australia | Hornsby Hospital | Hornsby | New South Wales |
Australia | Ipswich Hospital | Ipswich | Queensland |
Australia | Joondalup Health Campus | Joondalup | Western Australia |
Australia | Manly Hospital | Manly | New South Wales |
Australia | Logan Hospital | Meadowbrook | Queensland |
Australia | Austin Hospital | Melbourne | Victoria |
Australia | Modbury Hospital | Modnury | South Australia |
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | John Hunter Hospital | Newcastle | New South Wales |
Australia | Royal Melbourne Hospital | Parkville | Victoria |
Australia | Nepean Hospital | Penrith | New South Wales |
Australia | Royal Perth Hospital | Perth | Western Australia |
Australia | Port Macquarie Base | Port Macquarie | New South Wales |
Australia | The Alfred | Prahan | Victoria |
Australia | Prince of Wales Hospital (Sydney) | Randwick | New South Wales |
Australia | Central Gippsland (Sale Hospital) | Sale | Victoria |
Australia | Liverpool Hospital | Sydney | New South Wales |
Australia | Royal North Shore Hospital | Sydney | New South Wales |
Australia | Sydney Adventist hospital | Sydney | New South Wales |
Australia | Tamworth Hospital | Tamworth | New South Wales |
Australia | Toowoomba Hospital | Toowoomba | Queensland |
Australia | Westmead Hospital | Westmead | New South Wales |
Australia | Princess Alexandra | Woolloongabba | Queensland |
Finland | Helsinki University Hospital | Helsinki | |
Finland | Tampere University Hospital | Tampere | |
Hong Kong | Pamela Youde Nethersole Eastern Hospital (HK) | Chai Wan | |
Hong Kong | Prince of Wales Hospital | Hong Kong | Hong Hong |
Hong Kong | The Queen Elizabeth Hospital (HK) | Kowloon, | |
Ireland | St. Vincent's University hospital | Dublin | |
New Zealand | Auckland City Hospital | Auckland | |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | Middlemore Hospital | Otahuhu AUCKLAND | Auckland |
Lead Sponsor | Collaborator |
---|---|
Belinda Howe | Australasian College for Emergency Medicine, Australian and New Zealand Intensive Care Society Clinical Trials Group |
Australia, Finland, Hong Kong, Ireland, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure for the study is death from all causes | 90 days | No | |
Secondary | Death from all causes | 28 days, and at ICU and hospital discharge | No | |
Secondary | Quality of life as measured by the SF-36v2, EQ-5D and the AQoL | 6 and 12 months post-randomisation | No | |
Secondary | Duration of ED, ICU and hospital stay | 28 days and 90 days | No | |
Secondary | The need for, and duration of, artificial organ support | 28 days and 90 days | No |
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