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Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial

NCT00975793 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2014-04-24

No results posted yet for this study

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.

Conditions

  • Severe Sepsis

Interventions

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.

Sponsors & Collaborators

  • Australian and New Zealand Intensive Care Society Clinical Trials Group

    collaborator NETWORK

  • Australasian College for Emergency Medicine

    collaborator OTHER

  • Belinda Howe

    lead OTHER

Principal Investigators

  • Rinaldo Bellomo · Austin Hospital, Melbourne Australia

  • Sandra L Peake · The Queen Elizabeth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2014-07-31
Completion
2015-04-30

Countries

  • Australia
  • Finland
  • Hong Kong
  • Ireland
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00975793 on ClinicalTrials.gov