AzTrials
AzTrials

Severe SepsisPhase 3ARISENCT00975793

Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial

A Phase 3 study testing Early Goal Directed Therapy (EGDT) in people with Severe Sepsis, run by Belinda Howe at 51 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Sepsis
What is being tested?
Early Goal Directed Therapy (EGDT)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
51 sitesin 5 countries
Study dates
Oct 2008to Apr 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

51 sites in 5 countries.

51 sites in 5 countries

Australia42 sites

  • The Queen Elizabeth Hospital

    Adelaide, South Australia, 5011

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Bendigo Hospital

    Bendigo, Victoria

  • Blacktown Hospital

    Blacktown, Victoria

  • Box Hill Hospital

    Box Hill, Victoria

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales

  • Monash Medical Centre

    Clayton, Victoria

  • Coffs Harbour Hospital

    Coffs Harbour, New South Wales

  • Dandenong Hospital

    Dandenong, Victoria

  • St Vincent's Hospital (Sydney)

    Darlinghurst, New South Wales

  • Townsville Hospital

    Douglas, Queensland

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia

  • St Vincent's Hospital (Melbourne)

    Fitzroy, Victoria

  • Western Hospital

    Footscray, Victoria

  • Frankston Hospital

    Frankston, Victoria

  • Canberra Hospital

    Garran, Australian Capital Territory

  • Geelong Hospital

    Geelong, Victoria

  • Gosford Hospital

    Gosford, New South Wales

  • Royal Brisbane and Women's Hospital

    Herston Brisbane, Queensland

  • Hornsby Hospital

    Hornsby, New South Wales

  • Ipswich Hospital

    Ipswich, Queensland

  • Joondalup Health Campus

    Joondalup, Western Australia

  • Manly Hospital

    Manly, New South Wales

  • Logan Hospital

    Meadowbrook, Queensland

  • Austin Hospital

    Melbourne, Victoria, 3084

  • Modbury Hospital

    Modnury, South Australia

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia

  • John Hunter Hospital

    Newcastle, New South Wales

  • Royal Melbourne Hospital

    Parkville, Victoria

  • Nepean Hospital

    Penrith, New South Wales

  • Royal Perth Hospital

    Perth, Western Australia, 6001

  • Port Macquarie Base

    Port Macquarie, New South Wales

  • The Alfred

    Prahan, Victoria

  • Prince of Wales Hospital (Sydney)

    Randwick, New South Wales

  • Central Gippsland (Sale Hospital)

    Sale, Victoria

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065

  • Liverpool Hospital

    Sydney, New South Wales, 2170

  • Sydney Adventist hospital

    Sydney, New South Wales

  • Tamworth Hospital

    Tamworth, New South Wales

  • Toowoomba Hospital

    Toowoomba, Queensland

  • Westmead Hospital

    Westmead, New South Wales

  • Princess Alexandra

    Woolloongabba, Queensland

Other trials in Australia

Hong Kong3 sites

  • Pamela Youde Nethersole Eastern Hospital (HK)

    Chai Wan, Hong Kong

  • Prince of Wales Hospital

    Hong Kong, Hong Hong

  • The Queen Elizabeth Hospital (HK)

    Kowloon, Hong Kong

Other trials in Hong Kong

New Zealand3 sites

  • Auckland City Hospital

    Auckland

  • Christchurch Hospital

    Christchurch, New Zealand

  • Middlemore Hospital

    Otahuhu Auckland, Auckland

Other trials in New Zealand

Finland2 sites

  • Helsinki University Hospital

    Helsinki, Finland

  • Tampere University Hospital

    Tampere, Finland

Other trials in Finland

Ireland1 site

  • St. Vincent's University hospital

    Dublin

Other trials in Ireland

About this study

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

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.

Read the 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.

Conditions
Severe Sepsis
Being tested
Early Goal Directed Therapy (EGDT)
Keywords
Sepsis, Severe sepsis, Septic shock
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Goal Directed Therapy (EGDT)Other

    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.

Study groups in NCT00975793
Study groupRoleWhat they receive
Standard CareNo interventionRandomised allocation of standard care at the clinician's discretion in accordance with current best practice.
Early Goal Directed TherapyExperimentalRandomised allocation of early goal-directed therapy (EGDT).
Receives: Other: Early Goal Directed Therapy (EGDT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 90 days

Secondary outcomes (4)

  1. Death from all causes

    Measured: 28 days, and at ICU and hospital discharge

  2. Quality of life as measured by the SF-36v2, EQ-5D and the AQoL

    Measured: 6 and 12 months post-randomisation

  3. Duration of ED, ICU and hospital stay

    Measured: 28 days and 90 days

  4. The need for, and duration of, artificial organ support

    Measured: 28 days and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2014 (estimated)
  4. Study completionApr 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00975793
Sponsor's protocol ID
ANZIC - RC/RB001
Other IDs
NHMRC Project grant no. 491075
Acronym
ARISE
Status last verified
Apr 2014
First submitted
10 Sep 2009
Last updated
24 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Higgins AM, Peake SL, Rinaldo Bellomo AO, Ao DJC, Delaney A, Howe BD, Nichol AD, Webb SA, Williams PJ, Harris AH; ARISE Investigators and the ANZICS Clinical Trials Group. The cost-effectiveness of early goal-directed therapy: an economic evaluation alongside the ARISE trial. Crit Care Resusc. 2023 Oct 18;23(3):329-336. doi: 10.51893/2021.3.OA10. eCollection 2021 Sep 6.

    PubMed 38046082

  • 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.

    PubMed 30985391

  • 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.

    PubMed 25272316

  • 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.

    PubMed 24099368

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Early Goal Directed Therapy (EGDT) in people with Severe Sepsis, run by Belinda Howe at 51 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Australia, Hong Kong, New Zealand, Finland, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome measure for the study is death from all causes (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00975793, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in