Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial (ARISE)

This study is currently recruiting participants.
Verified April 2014 by Monash University
Sponsor:
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 3, 2014
Last verified: April 2014
  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: 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: April 2015
Estimated Primary Completion Date: July 2014 (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.
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

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 Locations
Locations
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         
Coffs Harbour Hospital Recruiting
Coffs Harbour, New South Wales, Australia
Contact: Alan Tankal         
Principal Investigator: Alan Tankal         
St Vincent's Hospital (Sydney) Recruiting
Darlinghurst, New South Wales, Australia
Contact: Priya Nair         
Contact: Claire Reynolds         
Principal Investigator: Priya Nair         
Gosford Hospital Active, not recruiting
Gosford, New South Wales, Australia
Hornsby Hospital Recruiting
Hornsby, New South Wales, Australia
Contact: James Fratzia         
Contact: Jay R Halkhoree (CNC)         
Principal Investigator: James Fratzia         
Manly Hospital Terminated
Manly, New South Wales, Australia
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         
Sydney Adventist hospital Recruiting
Sydney, New South Wales, Australia
Contact: Roger Harris         
Principal Investigator: Roger Harris         
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         
Toowoomba Hospital Recruiting
Toowoomba, Queensland, Australia
Contact: Manimozhi Vellaichamy         
Principal Investigator: Manimozhi Vellaichamy         
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         
Modbury Hospital Recruiting
Modnury, South Australia, Australia
Contact: Rachel Wells         
Principal Investigator: rachel Wells         
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 Active, not recruiting
Box Hill, Victoria, Australia
Monash Medical Centre Recruiting
Clayton, Victoria, Australia
Contact: David Lightfoot         
Contact: Pauline Galt         
Principal Investigator: David Lightfoot         
Dandenong Hospital Active, not recruiting
Dandenong, Victoria, Australia
St Vincent's Hospital (Melbourne) Active, not recruiting
Fitzroy, Victoria, Australia
Western Hospital Recruiting
Footscray, Victoria, Australia
Contact: Craig French         
Contact: Samantha Bates         
Principal Investigator: Craig French         
Frankston Hospital Active, not recruiting
Frankston, Victoria, Australia
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: Anne Kuitunen         
Hong Kong
Prince of Wales Hospital Terminated
Hong Kong, Hong Hong, 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         
Ireland
St. Vincent's University hospital Recruiting
Dublin, Ireland
Contact: Alistair Nichol         
Principal Investigator: Alistair Nichol         
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 by Monash University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 3, 2014
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 April 17, 2014