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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.
 
ClinicalTrials.gov 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
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

Tracking Information
First Submitted Date  ICMJE September 10, 2009
First Posted Date  ICMJE September 11, 2009
Last Update Posted Date April 24, 2014
Study Start Date  ICMJE October 2008
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2009)
The primary outcome measure for the study is death from all causes [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2009)
  • Death from all causes [ Time Frame: 28 days, and at ICU and hospital discharge ]
  • Quality of life as measured by the SF-36v2, EQ-5D and the AQoL [ Time Frame: 6 and 12 months post-randomisation ]
  • Duration of ED, ICU and hospital stay [ Time Frame: 28 days and 90 days ]
  • The need for, and duration of, artificial organ support [ Time Frame: 28 days and 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
Official Title  ICMJE A Multi-centre, Randomised Controlled Trial of Early Goal-directed Therapy in Patients Presenting to the Emergency Department With Severe Sepsis in Australasia
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Sepsis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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).
    Intervention: Other: Early Goal Directed Therapy (EGDT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 10, 2009)
1600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2015
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Finland,   Hong Kong,   Ireland,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00975793
Other Study ID Numbers  ICMJE ANZIC - RC/RB001
NHMRC Project grant no. 491075
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Belinda Howe, Monash University
Study Sponsor  ICMJE Belinda Howe
Collaborators  ICMJE
  • Australian and New Zealand Intensive Care Society Clinical Trials Group
  • Australasian College for Emergency Medicine
Investigators  ICMJE
Principal Investigator: Rinaldo Bellomo Austin Hospital, Melbourne Australia
Study Chair: Sandra L Peake The Queen Elizabeth Hospital
PRS Account Monash University
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP