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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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NHMRC Project grant no. 491075
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Secondary ID [2]
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ANZIC - RC/RB001
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Universal Trial Number (UTN)
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Trial acronym
ARISE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Severe Sepsis
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Injuries and Accidents
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Poisoning
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Blood
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Other blood disorders
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Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The primary outcome measure for the study is death from all causes
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Assessment method [1]
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Timepoint [1]
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90 days
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Secondary outcome [1]
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Death from all causes
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Assessment method [1]
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Timepoint [1]
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28 days, and at ICU and hospital discharge
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Secondary outcome [2]
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Quality of life as measured by the SF-36v2, EQ-5D and the AQoL
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Assessment method [2]
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Timepoint [2]
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6 and 12 months post-randomisation
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Secondary outcome [3]
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Duration of ED, ICU and hospital stay
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Assessment method [3]
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Timepoint [3]
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28 days and 90 days
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Secondary outcome [4]
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The need for, and duration of, artificial organ support
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Assessment method [4]
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Timepoint [4]
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28 days and 90 days
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2015
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Actual
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Sample size
Target
1600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Coffs Harbour Hospital - Coffs Harbour
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Recruitment hospital [4]
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St Vincent's Hospital (Sydney) - Darlinghurst
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Recruitment hospital [5]
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Gosford Hospital - Gosford
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Recruitment hospital [6]
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Hornsby Hospital - Hornsby
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Recruitment hospital [7]
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Manly Hospital - Manly
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Recruitment hospital [8]
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John Hunter Hospital - Newcastle
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Recruitment hospital [9]
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Nepean Hospital - Penrith
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Recruitment hospital [10]
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Port Macquarie Base - Port Macquarie
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Recruitment hospital [11]
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Prince of Wales Hospital (Sydney) - Randwick
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Recruitment hospital [12]
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Royal North Shore Hospital - Sydney
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Recruitment hospital [13]
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Liverpool Hospital - Sydney
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Recruitment hospital [14]
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Sydney Adventist hospital - Sydney
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Recruitment hospital [15]
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Tamworth Hospital - Tamworth
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Recruitment hospital [16]
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Westmead Hospital - Westmead
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Recruitment hospital [17]
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Townsville Hospital - Douglas
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Recruitment hospital [18]
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Royal Brisbane and Women's Hospital - Herston Brisbane
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Recruitment hospital [19]
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Ipswich Hospital - Ipswich
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Recruitment hospital [20]
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Logan Hospital - Meadowbrook
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Recruitment hospital [21]
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Toowoomba Hospital - Toowoomba
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Recruitment hospital [22]
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Princess Alexandra - Woolloongabba
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Recruitment hospital [23]
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The Queen Elizabeth Hospital - Adelaide
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Recruitment hospital [24]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [25]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [26]
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Modbury Hospital - Modnury
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Recruitment hospital [27]
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Bendigo Hospital - Bendigo
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Recruitment hospital [28]
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Blacktown Hospital - Blacktown
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Recruitment hospital [29]
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Box Hill Hospital - Box Hill
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Recruitment hospital [30]
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Monash Medical Centre - Clayton
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Recruitment hospital [31]
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Dandenong Hospital - Dandenong
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Recruitment hospital [32]
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St Vincent's Hospital (Melbourne) - Fitzroy
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Recruitment hospital [33]
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Western Hospital - Footscray
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Frankston Hospital - Frankston
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Recruitment hospital [35]
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Geelong Hospital - Geelong
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Recruitment hospital [36]
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Austin Hospital - Melbourne
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Recruitment hospital [37]
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Royal Melbourne Hospital - Parkville
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The Alfred - Prahan
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Central Gippsland (Sale Hospital) - Sale
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Joondalup Health Campus - Joondalup
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Recruitment hospital [41]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [42]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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- Garran
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Recruitment postcode(s) [2]
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- Camperdown
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Recruitment postcode(s) [3]
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- Coffs Harbour
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Recruitment postcode(s) [4]
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- Darlinghurst
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Recruitment postcode(s) [5]
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- Gosford
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Recruitment postcode(s) [6]
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- Hornsby
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Recruitment postcode(s) [7]
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- Manly
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Recruitment postcode(s) [8]
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- Newcastle
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Recruitment postcode(s) [9]
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- Penrith
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Recruitment postcode(s) [10]
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- Port Macquarie
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Recruitment postcode(s) [11]
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- Randwick
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Recruitment postcode(s) [12]
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2065 - Sydney
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Recruitment postcode(s) [13]
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2170 - Sydney
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Recruitment postcode(s) [14]
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- Sydney
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Recruitment postcode(s) [15]
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- Tamworth
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Recruitment postcode(s) [16]
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- Westmead
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Recruitment postcode(s) [17]
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- Douglas
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Recruitment postcode(s) [18]
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- Herston Brisbane
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Recruitment postcode(s) [19]
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- Ipswich
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Recruitment postcode(s) [20]
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- Meadowbrook
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Recruitment postcode(s) [21]
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- Toowoomba
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Recruitment postcode(s) [22]
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- Woolloongabba
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Recruitment postcode(s) [23]
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5011 - Adelaide
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Recruitment postcode(s) [24]
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- Adelaide
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Recruitment postcode(s) [25]
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- Elizabeth Vale
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Recruitment postcode(s) [26]
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- Modnury
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Recruitment postcode(s) [27]
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- Bendigo
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Recruitment postcode(s) [28]
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- Blacktown
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Recruitment postcode(s) [29]
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- Box Hill
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Recruitment postcode(s) [30]
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- Clayton
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Recruitment postcode(s) [31]
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- Dandenong
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Recruitment postcode(s) [32]
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- Fitzroy
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Recruitment postcode(s) [33]
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- Footscray
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Recruitment postcode(s) [34]
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- Frankston
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Recruitment postcode(s) [35]
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- Geelong
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Recruitment postcode(s) [36]
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3084 - Melbourne
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Recruitment postcode(s) [37]
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- Parkville
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Recruitment postcode(s) [38]
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- Prahan
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Recruitment postcode(s) [39]
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- Sale
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Recruitment postcode(s) [40]
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- Joondalup
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Recruitment postcode(s) [41]
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- Nedlands
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Recruitment postcode(s) [42]
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6001 - Perth
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Recruitment outside Australia
Country [1]
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Finland
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State/province [1]
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Helsinki
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Country [2]
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Finland
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State/province [2]
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Tampere
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Country [3]
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Hong Kong
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State/province [3]
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Hong Hong
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Country [4]
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Hong Kong
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State/province [4]
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Chai Wan
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Country [5]
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Hong Kong
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State/province [5]
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Kowloon,
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Country [6]
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Ireland
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State/province [6]
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Dublin
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Country [7]
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New Zealand
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State/province [7]
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Auckland
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Country [8]
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New Zealand
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State/province [8]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
Belinda Howe
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australian and New Zealand Intensive Care Society Clinical Trials Group
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Australasian College for Emergency Medicine
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00975793
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Rinaldo Bellomo
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Address
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Austin Hospital, Melbourne Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00975793
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