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Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial (ARISE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Australian and New Zealand Intensive Care Society Clinical Trials Group
Australasian College for Emergency Medicine
Information provided by (Responsible Party):
Belinda Howe, Monash University
ClinicalTrials.gov Identifier:
NCT00975793
First received: September 10, 2009
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Severe Sepsis
Other: Early Goal Directed Therapy (EGDT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • The primary outcome measure for the study is death from all causes [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death from all causes [ Time Frame: 28 days, and at ICU and hospital discharge ] [ Designated as safety issue: No ]
  • Quality of life as measured by the SF-36v2, EQ-5D and the AQoL [ Time Frame: 6 and 12 months post-randomisation ] [ Designated as safety issue: No ]
  • Duration of ED, ICU and hospital stay [ Time Frame: 28 days and 90 days ] [ Designated as safety issue: No ]
  • The need for, and duration of, artificial organ support [ Time Frame: 28 days and 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: October 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975793

  Show 51 Study Locations
Sponsors and Collaborators
Belinda Howe
Australian and New Zealand Intensive Care Society Clinical Trials Group
Australasian College for Emergency Medicine
Investigators
Principal Investigator: Rinaldo Bellomo Austin Hospital, Melbourne Australia
Study Chair: Sandra L Peake The Queen Elizabeth Hospital
  More Information

Additional Information:
No publications provided by Monash University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Belinda Howe, Project manager, ANZIC- Research Centre, Monash University, Monash University
ClinicalTrials.gov Identifier: NCT00975793     History of Changes
Other Study ID Numbers: ANZIC - RC/RB001, NHMRC Project grant no. 491075
Study First Received: September 10, 2009
Last Updated: April 23, 2014
Health Authority: Australia: National Health and Medical Research Council
Australia: Human Research Ethics Committee

Keywords provided by Monash University:
Sepsis
Severe sepsis
Septic shock

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 23, 2014