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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00975793




Registration number
NCT00975793
Ethics application status
Date submitted
10/09/2009
Date registered
11/09/2009
Date last updated
24/04/2014

Titles & IDs
Public title
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
Scientific title
A Multi-centre, Randomised Controlled Trial of Early Goal-directed Therapy in Patients Presenting to the Emergency Department With Severe Sepsis in Australasia
Secondary ID [1] 0 0
NHMRC Project grant no. 491075
Secondary ID [2] 0 0
ANZIC - RC/RB001
Universal Trial Number (UTN)
Trial acronym
ARISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Sepsis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Early Goal Directed Therapy (EGDT)

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 interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary outcome measure for the study is death from all causes
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Death from all causes
Timepoint [1] 0 0
28 days, and at ICU and hospital discharge
Secondary outcome [2] 0 0
Quality of life as measured by the SF-36v2, EQ-5D and the AQoL
Timepoint [2] 0 0
6 and 12 months post-randomisation
Secondary outcome [3] 0 0
Duration of ED, ICU and hospital stay
Timepoint [3] 0 0
28 days and 90 days
Secondary outcome [4] 0 0
The need for, and duration of, artificial organ support
Timepoint [4] 0 0
28 days and 90 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2015
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Coffs Harbour Hospital - Coffs Harbour
Recruitment hospital [4] 0 0
St Vincent's Hospital (Sydney) - Darlinghurst
Recruitment hospital [5] 0 0
Gosford Hospital - Gosford
Recruitment hospital [6] 0 0
Hornsby Hospital - Hornsby
Recruitment hospital [7] 0 0
Manly Hospital - Manly
Recruitment hospital [8] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [9] 0 0
Nepean Hospital - Penrith
Recruitment hospital [10] 0 0
Port Macquarie Base - Port Macquarie
Recruitment hospital [11] 0 0
Prince of Wales Hospital (Sydney) - Randwick
Recruitment hospital [12] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [13] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [14] 0 0
Sydney Adventist hospital - Sydney
Recruitment hospital [15] 0 0
Tamworth Hospital - Tamworth
Recruitment hospital [16] 0 0
Westmead Hospital - Westmead
Recruitment hospital [17] 0 0
Townsville Hospital - Douglas
Recruitment hospital [18] 0 0
Royal Brisbane and Women's Hospital - Herston Brisbane
Recruitment hospital [19] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [20] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [21] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [22] 0 0
Princess Alexandra - Woolloongabba
Recruitment hospital [23] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [24] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [25] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [26] 0 0
Modbury Hospital - Modnury
Recruitment hospital [27] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [28] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [29] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [30] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [31] 0 0
Dandenong Hospital - Dandenong
Recruitment hospital [32] 0 0
St Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [33] 0 0
Western Hospital - Footscray
Recruitment hospital [34] 0 0
Frankston Hospital - Frankston
Recruitment hospital [35] 0 0
Geelong Hospital - Geelong
Recruitment hospital [36] 0 0
Austin Hospital - Melbourne
Recruitment hospital [37] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [38] 0 0
The Alfred - Prahan
Recruitment hospital [39] 0 0
Central Gippsland (Sale Hospital) - Sale
Recruitment hospital [40] 0 0
Joondalup Health Campus - Joondalup
Recruitment hospital [41] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [42] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Coffs Harbour
Recruitment postcode(s) [4] 0 0
- Darlinghurst
Recruitment postcode(s) [5] 0 0
- Gosford
Recruitment postcode(s) [6] 0 0
- Hornsby
Recruitment postcode(s) [7] 0 0
- Manly
Recruitment postcode(s) [8] 0 0
- Newcastle
Recruitment postcode(s) [9] 0 0
- Penrith
Recruitment postcode(s) [10] 0 0
- Port Macquarie
Recruitment postcode(s) [11] 0 0
- Randwick
Recruitment postcode(s) [12] 0 0
2065 - Sydney
Recruitment postcode(s) [13] 0 0
2170 - Sydney
Recruitment postcode(s) [14] 0 0
- Sydney
Recruitment postcode(s) [15] 0 0
- Tamworth
Recruitment postcode(s) [16] 0 0
- Westmead
Recruitment postcode(s) [17] 0 0
- Douglas
Recruitment postcode(s) [18] 0 0
- Herston Brisbane
Recruitment postcode(s) [19] 0 0
- Ipswich
Recruitment postcode(s) [20] 0 0
- Meadowbrook
Recruitment postcode(s) [21] 0 0
- Toowoomba
Recruitment postcode(s) [22] 0 0
- Woolloongabba
Recruitment postcode(s) [23] 0 0
5011 - Adelaide
Recruitment postcode(s) [24] 0 0
- Adelaide
Recruitment postcode(s) [25] 0 0
- Elizabeth Vale
Recruitment postcode(s) [26] 0 0
- Modnury
Recruitment postcode(s) [27] 0 0
- Bendigo
Recruitment postcode(s) [28] 0 0
- Blacktown
Recruitment postcode(s) [29] 0 0
- Box Hill
Recruitment postcode(s) [30] 0 0
- Clayton
Recruitment postcode(s) [31] 0 0
- Dandenong
Recruitment postcode(s) [32] 0 0
- Fitzroy
Recruitment postcode(s) [33] 0 0
- Footscray
Recruitment postcode(s) [34] 0 0
- Frankston
Recruitment postcode(s) [35] 0 0
- Geelong
Recruitment postcode(s) [36] 0 0
3084 - Melbourne
Recruitment postcode(s) [37] 0 0
- Parkville
Recruitment postcode(s) [38] 0 0
- Prahan
Recruitment postcode(s) [39] 0 0
- Sale
Recruitment postcode(s) [40] 0 0
- Joondalup
Recruitment postcode(s) [41] 0 0
- Nedlands
Recruitment postcode(s) [42] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
Finland
State/province [2] 0 0
Tampere
Country [3] 0 0
Hong Kong
State/province [3] 0 0
Hong Hong
Country [4] 0 0
Hong Kong
State/province [4] 0 0
Chai Wan
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Kowloon,
Country [6] 0 0
Ireland
State/province [6] 0 0
Dublin
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
New Zealand
State/province [8] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Belinda Howe
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australasian College for Emergency Medicine
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00975793
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Rinaldo Bellomo
Address 0 0
Austin Hospital, Melbourne Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00975793