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Trial record 1 of 1 for:    nct00975793
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Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial (ARISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00975793
Recruitment Status : Unknown
Verified April 2014 by Belinda Howe, Monash University.
Recruitment status was:  Active, not recruiting
First Posted : September 11, 2009
Last Update Posted : April 24, 2014
Australian and New Zealand Intensive Care Society Clinical Trials Group
Australasian College for Emergency Medicine
Information provided by (Responsible Party):
Belinda Howe, Monash University

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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Other: Early Goal Directed Therapy (EGDT) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2008
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
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: 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.

Primary Outcome Measures :
  1. The primary outcome measure for the study is death from all causes [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Death from all causes [ Time Frame: 28 days, and at ICU and hospital discharge ]
  2. Quality of life as measured by the SF-36v2, EQ-5D and the AQoL [ Time Frame: 6 and 12 months post-randomisation ]
  3. Duration of ED, ICU and hospital stay [ Time Frame: 28 days and 90 days ]
  4. The need for, and duration of, artificial organ support [ Time Frame: 28 days and 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00975793

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Sponsors and Collaborators
Belinda Howe
Australian and New Zealand Intensive Care Society Clinical Trials Group
Australasian College for Emergency Medicine
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Principal Investigator: Rinaldo Bellomo Austin Hospital, Melbourne Australia
Study Chair: Sandra L Peake The Queen Elizabeth Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Belinda Howe, Project manager, ANZIC- Research Centre, Monash University, Monash University Identifier: NCT00975793    
Other Study ID Numbers: ANZIC - RC/RB001
NHMRC Project grant no. 491075
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014
Keywords provided by Belinda Howe, Monash University:
Severe sepsis
Septic shock
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes