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Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial (ARISE)

Primary Purpose

Severe Sepsis

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Early Goal Directed Therapy (EGDT)
Sponsored by
Belinda Howe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring Sepsis, Severe sepsis, Septic shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canberra Hospital
  • Royal Prince Alfred Hospital
  • Coffs Harbour Hospital
  • St Vincent's Hospital (Sydney)
  • Gosford Hospital
  • Hornsby Hospital
  • Manly Hospital
  • John Hunter Hospital
  • Nepean Hospital
  • Port Macquarie Base
  • Prince of Wales Hospital (Sydney)
  • Royal North Shore Hospital
  • Liverpool Hospital
  • Sydney Adventist hospital
  • Tamworth Hospital
  • Westmead Hospital
  • Townsville Hospital
  • Royal Brisbane and Women's Hospital
  • Ipswich Hospital
  • Logan Hospital
  • Toowoomba Hospital
  • Princess Alexandra
  • The Queen Elizabeth Hospital
  • Royal Adelaide Hospital
  • Lyell McEwin Hospital
  • Modbury Hospital
  • Bendigo Hospital
  • Blacktown Hospital
  • Box Hill Hospital
  • Monash Medical Centre
  • Dandenong Hospital
  • St Vincent's Hospital (Melbourne)
  • Western Hospital
  • Frankston Hospital
  • Geelong Hospital
  • Austin Hospital
  • Royal Melbourne Hospital
  • The Alfred
  • Central Gippsland (Sale Hospital)
  • Joondalup Health Campus
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Helsinki University Hospital
  • Tampere University Hospital
  • Prince of Wales Hospital
  • Pamela Youde Nethersole Eastern Hospital (HK)
  • The Queen Elizabeth Hospital (HK)
  • St. Vincent's University hospital
  • Middlemore Hospital
  • Auckland City Hospital
  • Christchurch Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Early Goal Directed Therapy

Arm Description

Randomised allocation of standard care at the clinician's discretion in accordance with current best practice.

Randomised allocation of early goal-directed therapy (EGDT).

Outcomes

Primary Outcome Measures

The primary outcome measure for the study is death from all causes

Secondary Outcome Measures

Death from all causes
Quality of life as measured by the SF-36v2, EQ-5D and the AQoL
Duration of ED, ICU and hospital stay
The need for, and duration of, artificial organ support

Full Information

First Posted
September 10, 2009
Last Updated
April 23, 2014
Sponsor
Belinda Howe
Collaborators
Australian and New Zealand Intensive Care Society Clinical Trials Group, Australasian College for Emergency Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00975793
Brief Title
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
Acronym
ARISE
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Belinda Howe
Collaborators
Australian and New Zealand Intensive Care Society Clinical Trials Group, Australasian College for Emergency Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
Sepsis, Severe sepsis, Septic shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Randomised allocation of standard care at the clinician's discretion in accordance with current best practice.
Arm Title
Early Goal Directed Therapy
Arm Type
Experimental
Arm Description
Randomised allocation of early goal-directed therapy (EGDT).
Intervention Type
Other
Intervention Name(s)
Early Goal Directed Therapy (EGDT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure for the study is death from all causes
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Death from all causes
Time Frame
28 days, and at ICU and hospital discharge
Title
Quality of life as measured by the SF-36v2, EQ-5D and the AQoL
Time Frame
6 and 12 months post-randomisation
Title
Duration of ED, ICU and hospital stay
Time Frame
28 days and 90 days
Title
The need for, and duration of, artificial organ support
Time Frame
28 days and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rinaldo Bellomo
Organizational Affiliation
Austin Hospital, Melbourne Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra L Peake
Organizational Affiliation
The Queen Elizabeth Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
Coffs Harbour Hospital
City
Coffs Harbour
State/Province
New South Wales
Country
Australia
Facility Name
St Vincent's Hospital (Sydney)
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
Country
Australia
Facility Name
Hornsby Hospital
City
Hornsby
State/Province
New South Wales
Country
Australia
Facility Name
Manly Hospital
City
Manly
State/Province
New South Wales
Country
Australia
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
Country
Australia
Facility Name
Nepean Hospital
City
Penrith
State/Province
New South Wales
Country
Australia
Facility Name
Port Macquarie Base
City
Port Macquarie
State/Province
New South Wales
Country
Australia
Facility Name
Prince of Wales Hospital (Sydney)
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Sydney Adventist hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Tamworth Hospital
City
Tamworth
State/Province
New South Wales
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Townsville Hospital
City
Douglas
State/Province
Queensland
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
Queensland
Country
Australia
Facility Name
Logan Hospital
City
Meadowbrook
State/Province
Queensland
Country
Australia
Facility Name
Toowoomba Hospital
City
Toowoomba
State/Province
Queensland
Country
Australia
Facility Name
Princess Alexandra
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
State/Province
South Australia
Country
Australia
Facility Name
Modbury Hospital
City
Modnury
State/Province
South Australia
Country
Australia
Facility Name
Bendigo Hospital
City
Bendigo
State/Province
Victoria
Country
Australia
Facility Name
Blacktown Hospital
City
Blacktown
State/Province
Victoria
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Dandenong Hospital
City
Dandenong
State/Province
Victoria
Country
Australia
Facility Name
St Vincent's Hospital (Melbourne)
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
Geelong Hospital
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
The Alfred
City
Prahan
State/Province
Victoria
Country
Australia
Facility Name
Central Gippsland (Sale Hospital)
City
Sale
State/Province
Victoria
Country
Australia
Facility Name
Joondalup Health Campus
City
Joondalup
State/Province
Western Australia
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
Hong Hong
Country
Hong Kong
Facility Name
Pamela Youde Nethersole Eastern Hospital (HK)
City
Chai Wan
Country
Hong Kong
Facility Name
The Queen Elizabeth Hospital (HK)
City
Kowloon,
Country
Hong Kong
Facility Name
St. Vincent's University hospital
City
Dublin
Country
Ireland
Facility Name
Middlemore Hospital
City
Otahuhu AUCKLAND
State/Province
Auckland
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
30985391
Citation
Higgins AM, Peake SL, Bellomo R, Cooper DJ, Delaney A, Harris AH, Howe BD, Nichol AD, Webb SA, Williams PJ; Australasian Resuscitation in Sepsis Evaluation (ARISE) Investigators and the ANZICS Clinical Trials Group. Quality of Life and 1-Year Survival in Patients With Early Septic Shock: Long-Term Follow-Up of the Australasian Resuscitation in Sepsis Evaluation Trial. Crit Care Med. 2019 Jun;47(6):765-773. doi: 10.1097/CCM.0000000000003762.
Results Reference
derived
PubMed Identifier
25272316
Citation
ARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.
Results Reference
derived
PubMed Identifier
24099368
Citation
Delaney A, Peake SL, Bellomo R, Cameron P, Holdgate A, Howe B, Higgins A, Presneill J, Webb S; ARISE Investigators. Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan. Emerg Med Australas. 2013 Oct;25(5):406-15. doi: 10.1111/1742-6723.12116. Epub 2013 Sep 9.
Results Reference
derived
Links:
URL
http://arise.org.au
Description
ARISE study website

Learn more about this trial

Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial

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