RecruitingPhase 3ACTRN12608000053325

Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial

A multi-centre, randomised controlled trial of the effect of early goal-directed therapy, compared to standard care, on 90-day mortality in patients presenting to the Emergency Department with severe sepsis in Australasia


Sponsor

Australian and New Zealand Intensive Care Research Centre

Enrollment

1,600 participants

Start Date

Oct 6, 2008

Study Type

Interventional

Conditions

Summary

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. The study will be conducted in 32 hospitals in Australasia with 1600 patients enrolled in the study over a 2.5 year period.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 0 N/As

Plain Language Summary

Simplified for easier understanding

This large study is testing whether a specific intensive treatment protocol called Early Goal-Directed Therapy (EGDT) reduces the risk of death in people who arrive at hospital emergency departments with severe sepsis (a life-threatening response to infection). EGDT involves very closely monitoring and adjusting blood flow and oxygen levels in the body during the first 6 hours after diagnosis. The study will compare this approach to standard emergency care across 32 hospitals in Australia and New Zealand. You may be eligible if: - You are 18 years of age or older - You are in an emergency department with a suspected or confirmed infection - You meet criteria for a serious body-wide inflammatory response (SIRS) - You show signs of low blood pressure or poor blood flow that is not responding to initial treatment You may NOT be eligible if: - There is a medical reason you cannot have a central venous catheter (a tube placed in a large vein) - You are unable to receive blood products - You are actively and severely bleeding - You are pregnant - You have a terminal illness with a life expectancy under 90 days - Your death is considered imminent - You transferred from another hospital Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 ca

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.


Locations(2)

New Zealand

Hong Kong

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ACTRN12608000053325