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

September 10, 2009
April 23, 2014
October 2008
July 2014   (final data collection date for primary outcome measure)
The primary outcome measure for the study is death from all causes [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00975793 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
A Multi-centre, Randomised Controlled Trial of Early Goal-directed Therapy in Patients Presenting to the Emergency Department With Severe Sepsis in Australasia

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Sepsis
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.
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1600
April 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Finland,   Hong Kong,   Ireland,   New Zealand
 
NCT00975793
ANZIC - RC/RB001, NHMRC Project grant no. 491075
Yes
Belinda Howe, Monash University
Belinda Howe
  • Australian and New Zealand Intensive Care Society Clinical Trials Group
  • Australasian College for Emergency Medicine
Principal Investigator: Rinaldo Bellomo Austin Hospital, Melbourne Australia
Study Chair: Sandra L Peake The Queen Elizabeth Hospital
Monash University
April 2014

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