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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00975793
Other study ID # ANZIC - RC/RB001
Secondary ID NHMRC Project gr
Status Active, not recruiting
Phase Phase 3
First received September 10, 2009
Last updated April 23, 2014
Start date October 2008
Est. completion date April 2015

Study information

Verified date April 2014
Source Monash University
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research CouncilAustralia: Human Research Ethics Committee
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Belinda Howe Australasian College for Emergency Medicine, Australian and New Zealand Intensive Care Society Clinical Trials Group

Countries where clinical trial is conducted

Australia,  Finland,  Hong Kong,  Ireland,  New Zealand, 

Outcome

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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