Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial (ARISE)
This study is currently recruiting participants.
Verified April 2012 by Monash University
Sponsor:
Belinda Howe
Collaborators:
Australian and New Zealand Intensive Care Society Clinical Trials Group
Australasian College for Emergency Medicine
Information provided by (Responsible Party):
Belinda Howe, Monash University
ClinicalTrials.gov Identifier:
NCT00975793
First received: September 10, 2009
Last updated: April 10, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Sepsis |
Other: Standard Care Other: Early Goal Directed Therapy (EGDT) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-centre, Randomised Controlled Trial of Early Goal-directed Therapy in Patients Presenting to the Emergency Department With Severe Sepsis in Australasia |
Resource links provided by NLM:
Further study details as provided by Monash University:
Primary Outcome Measures:
- The primary outcome measure for the study is death from all causes [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Death from all causes [ Time Frame: 28 days, and at ICU and hospital discharge ] [ Designated as safety issue: No ]
- Quality of life as measured by the SF-36v2, EQ-5D and the AQoL [ Time Frame: 6 and 12 months post-randomisation ] [ Designated as safety issue: No ]
- Duration of ED, ICU and hospital stay [ Time Frame: 28 days and 90 days ] [ Designated as safety issue: No ]
- The need for, and duration of, artificial organ support [ Time Frame: 28 days and 90 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1600 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Standard Care
Randomised allocation of standard care at the clinician's discretion in accordance with current best practice.
|
Other: Standard Care
Standard care at the clinician's discretion in accordance with current best practice. Standard treatment may involve treatment with intravenous fluids, and medications to support the blood pressure and heart. Treatment is not given according to a protocol and may include some of the treatments given in the EGDT arm.
|
|
Experimental: Early Goal Directed Therapy
Randomised allocation of early goal-directed therapy (EGDT).
|
Other: Early Goal Directed Therapy (EGDT)
Randomised allocation of early goal-directed therapy (EGDT). EGDT involves treatment with intravenous fluids, and medications to support the blood pressure and heart following a protocol. A special catheter is inserted to monitor central blood oxygen levels and the standard treatments are given according to the blood oxygen level reading. EGDT is given for 6 hours, then the patient receives standard care.
|
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.
Each patient meeting all of the exclusion criteria and none of the exclusion criteria will be randomised in the ED to receive either EGDT for a total of 6 hours post-randomisation, or standard care.
Patients assigned to receive EGDT will be cared for by the dedicated ARISE study team. The patient will receive treatment as per the study protocol for 6 hours with central blood oxygen levels as the target end-point, then receive standard care.
Patients assigned to receive standard care will continue to be cared for by the hospital team in accordance with current best practice.
Patients in both groups will also receive any additional treatment needed, such as antibiotics or surgery.
This study will involve 1600 patients with severe sepsis admitted to the ED from multiple hospitals.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975793
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Contacts
| Contact: Belinda Howe | +61 3 9903 0340 | belinda.howe@monash.edu |
| Contact: Lorraine Little | +61 3 9903 0513 | lorraine.little@monash.edu |
Hide Study LocationsLocations
| Australia, Australian Capital Territory | |
| Canberra Hospital | Recruiting |
| Garran, Australian Capital Territory, Australia | |
| Contact: Kelvin Grove | |
| Contact: Helen Rodgers | |
| Principal Investigator: Kelvin Grove | |
| Australia, New South Wales | |
| Royal Prince Alfred Hospital | Recruiting |
| Camperdown, New South Wales, Australia | |
| Contact: David Gattas | |
| Contact: Heidi Buhr | |
| Principal Investigator: David Gattas | |
| St Vincent's Hospital (Sydney) | Recruiting |
| Darlinghurst, New South Wales, Australia | |
| Contact: Priya Nair | |
| Contact: Claire Reynolds | |
| Principal Investigator: Priya Nair | |
| Gosford Hospital | Recruiting |
| Gosford, New South Wales, Australia | |
| Contact: Sean Kelly | |
| Contact: Nichole Woodward | |
| Principal Investigator: Sean Kelly | |
| Hornsby Hospital | Recruiting |
| Hornsby, New South Wales, Australia | |
| Contact: James Fratzia | |
| Contact: Jay R Halkhoree (CNC) | |
| Principal Investigator: James Fratzia | |
| Manly Hospital | Recruiting |
| Manly, New South Wales, Australia | |
| Contact: Michelle Franks | |
| Contact: Sue Coulson | |
| Principal Investigator: Michelle Franks | |
| John Hunter Hospital | Recruiting |
| Newcastle, New South Wales, Australia | |
| Contact: Peter Harrigan | |
| Principal Investigator: Peter Harrigan | |
| Nepean Hospital | Recruiting |
| Penrith, New South Wales, Australia | |
| Contact: Ian Seppelt | |
| Contact: Tracey Clarke | |
| Principal Investigator: Ian Seppelt | |
| Port Macquarie Base | Recruiting |
| Port Macquarie, New South Wales, Australia | |
| Contact: Bill Lancashire | |
| Contact: Antony Altea | |
| Principal Investigator: Bill Lancashire | |
| Prince of Wales Hospital (Sydney) | Recruiting |
| Randwick, New South Wales, Australia | |
| Contact: Yahya Shehabi | |
| Contact: Pam Edhouse | |
| Principal Investigator: Yahya Shehabi | |
| Liverpool Hospital | Recruiting |
| Sydney, New South Wales, Australia, 2170 | |
| Contact: Anna Holdgate | |
| Contact: Sharon Micallef | |
| Principal Investigator: Anna Holdgate | |
| Royal North Shore Hospital | Recruiting |
| Sydney, New South Wales, Australia, 2065 | |
| Contact: Anthony Delaney | |
| Contact: Simon Bird | |
| Principal Investigator: Anthony Delaney | |
| Tamworth Hospital | Recruiting |
| Tamworth, New South Wales, Australia | |
| Contact: Christopher Trethewy | |
| Contact: Julie Burrows | |
| Principal Investigator: Christopher Trethewy | |
| Westmead Hospital | Recruiting |
| Westmead, New South Wales, Australia | |
| Contact: Daniel O'Flynn | |
| Contact: James Kwans | |
| Principal Investigator: James Kwans | |
| Australia, Queensland | |
| Townsville Hospital | Recruiting |
| Douglas, Queensland, Australia | |
| Contact: Geoff Gordon | |
| Contact: Stephen Reeves | |
| Principal Investigator: Geoff Gordon | |
| Royal Brisbane and Women's Hospital | Recruiting |
| Herston Brisbane, Queensland, Australia | |
| Contact: Julian Williams | |
| Contact: Jaimi Greenslade | |
| Principal Investigator: Julian Williams | |
| Ipswich Hospital | Recruiting |
| Ipswich, Queensland, Australia | |
| Contact: James Walsham | |
| Contact: Kristine Ryan | |
| Principal Investigator: James Walsham | |
| Logan Hospital | Recruiting |
| Meadowbrook, Queensland, Australia | |
| Contact: Hayden White | |
| Contact: Lynne Morrison | |
| Principal Investigator: Hayden White | |
| Princess Alexandra | Recruiting |
| Woolloongabba, Queensland, Australia | |
| Contact: Sean Lawrence | |
| Contact: Katherine Isoardi | |
| Principal Investigator: Sean Lawrence | |
| Australia, South Australia | |
| Royal Adelaide Hospital | Recruiting |
| Adelaide, South Australia, Australia | |
| Contact: Krish Sundararajan | |
| Contact: Stephanie O'Connor | |
| Principal Investigator: Krish Sundararajan | |
| The Queen Elizabeth Hospital | Recruiting |
| Adelaide, South Australia, Australia, 5011 | |
| Contact: Sandra Peake | |
| Contact: Tricia Williams | |
| Principal Investigator: Sandra L Peake | |
| Lyell McEwin Hospital | Recruiting |
| Elizabeth Vale, South Australia, Australia | |
| Contact: Rajaram Ramadoss | |
| Contact: Josette Wood | |
| Principal Investigator: Rajaram Ramadoss | |
| Australia, Victoria | |
| Bendigo Hospital | Recruiting |
| Bendigo, Victoria, Australia | |
| Contact: Jason Fletcher | |
| Contact: Julie Smith | |
| Principal Investigator: Jason Fletcher | |
| Blacktown Hospital | Recruiting |
| Blacktown, Victoria, Australia | |
| Contact: Dhaval Ghelani | |
| Contact: Kiran Nand | |
| Principal Investigator: Dhavel Ghelani | |
| Box Hill Hospital | Recruiting |
| Box Hill, Victoria, Australia | |
| Contact: Anthony Cross | |
| Contact: Michelle Brummisch | |
| Principal Investigator: Anthony Cross | |
| Monash Medical Centre | Recruiting |
| Clayton, Victoria, Australia | |
| Contact: David Lightfoot | |
| Contact: Pauline Galt | |
| Principal Investigator: David Lightfoot | |
| Dandenong Hospital | Recruiting |
| Dandenong, Victoria, Australia | |
| Contact: Sanjiv Vij | |
| Contact: Bridget O'Bree | |
| Principal Investigator: Sanjiv Vij | |
| St Vincent's Hospital (Melbourne) | Recruiting |
| Fitzroy, Victoria, Australia | |
| Contact: Craig Winter | |
| Contact: Deets Faraone | |
| Principal Investigator: Craig Winter | |
| Western Hospital | Recruiting |
| Footscray, Victoria, Australia | |
| Contact: Craig French | |
| Contact: Samantha Bates | |
| Principal Investigator: Craig French | |
| Frankston Hospital | Recruiting |
| Frankston, Victoria, Australia | |
| Contact: Kavi Haji | |
| Contact: David Lewis | |
| Principal Investigator: Kavi Haji | |
| Geelong Hospital | Recruiting |
| Geelong, Victoria, Australia | |
| Contact: Neil Orford | |
| Contact: Allison Bone | |
| Principal Investigator: Neil Orford | |
| Austin Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3084 | |
| Contact: Rinaldo Bellomo | |
| Contact: Glenn Eastwood | |
| Principal Investigator: Rinaldo - Bellomo | |
| Royal Melbourne Hospital | Recruiting |
| Parkville, Victoria, Australia | |
| Contact: Christopher Macisaac | |
| Contact: Andrea Jordan | |
| Principal Investigator: Christopher Macisaac | |
| The Alfred | Recruiting |
| Prahan, Victoria, Australia | |
| Contact: Jamie Cooper | |
| Contact: Vic Bennett | |
| Principal Investigator: Jamie Cooper | |
| Central Gippsland (Sale Hospital) | Recruiting |
| Sale, Victoria, Australia | |
| Contact: Rob Ziffer | |
| Contact: Jennifer Dennett (NUM) | |
| Principal Investigator: Rob Ziffer | |
| Australia, Western Australia | |
| Joondalup Health Campus | Recruiting |
| Joondalup, Western Australia, Australia | |
| Contact: Conway Tang | |
| Contact: Sammy Brown | |
| Principal Investigator: Conway Tang | |
| Sir Charles Gairdner Hospital | Recruiting |
| Nedlands, Western Australia, Australia | |
| Contact: Stuart Baker | |
| Contact: Brigit Roberts | |
| Principal Investigator: Stuart Baker | |
| Royal Perth Hospital | Recruiting |
| Perth, Western Australia, Australia, 6001 | |
| Contact: Steve Webb | |
| Contact: Jenny Chamberlain | |
| Principal Investigator: Steve Webb | |
| Finland | |
| Helsinki University Hospital | Recruiting |
| Helsinki, Finland | |
| Contact: Ville Pettila | |
| Principal Investigator: Ville Pettila | |
| Tampere University Hospital | Recruiting |
| Tampere, Finland | |
| Contact: Jyrki Tenhunen | |
| Principal Investigator: Jyrki Tenhunen | |
| Hong Kong | |
| Pamela Youde Nethersole Eastern Hospital (HK) | Recruiting |
| Chai Wan, Hong Kong | |
| Contact: Sin Man (Grace) Lam | |
| Principal Investigator: Sin Man (Grace) Lam | |
| The Queen Elizabeth Hospital (HK) | Recruiting |
| Kowloon,, Hong Kong | |
| Contact: Anne Leung | |
| Principal Investigator: Anne Leung | |
| New Zealand | |
| Middlemore Hospital | Recruiting |
| Otahuhu AUCKLAND, Auckland, New Zealand | |
| Contact: Tony Williams | |
| Contact: Chantal Hogan | |
| Principal Investigator: Tony Williams | |
| Auckland City Hospital | Recruiting |
| Auckland, New Zealand | |
| Contact: Peter Jones | |
| Contact: Fran Sawtell | |
| Principal Investigator: Peter Jones | |
| Christchurch Hospital | Recruiting |
| Christchurch, New Zealand | |
| Contact: Seton Henderson | |
| Contact: Jan Mehrtens | |
| Principal Investigator: Seton Henderson | |
Sponsors and Collaborators
Belinda Howe
Australian and New Zealand Intensive Care Society Clinical Trials Group
Australasian College for Emergency Medicine
Investigators
| Principal Investigator: | Rinaldo Bellomo | Austin Hospital, Melbourne Australia |
| Study Chair: | Sandra L Peake | The Queen Elizabeth Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Belinda Howe, Project manager, ANZIC- Research Centre, Monash University, Monash University |
| ClinicalTrials.gov Identifier: | NCT00975793 History of Changes |
| Other Study ID Numbers: | ANZIC - RC/RB001, NHMRC Project grant no. 491075 |
| Study First Received: | September 10, 2009 |
| Last Updated: | April 10, 2012 |
| Health Authority: | Australia: National Health and Medical Research Council Australia: Human Research Ethics Committee |
Keywords provided by Monash University:
|
Sepsis Severe sepsis Septic shock |
Additional relevant MeSH terms:
|
Sepsis Toxemia Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013