ARISE
Goal-directed resuscitation for patients with early septic shock
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Overview
In ED patients with early septic shock, EGDT did not reduce 90-day mortality compared with usual care.
Clinical takeaway
ARISE showed that protocolized EGDT added fluids, vasopressors, transfusion, and dobutamine without improving 90-day survival over usual emergency-department care.
Key result
90-day mortality was 18.6% with EGDT vs 18.8% with usual care (absolute risk difference -0.3 percentage points; 95% CI -4.1 to 3.6; p=0.90).
Practice impact
Supports timely septic-shock care without a mandatory EGDT protocol.
Evidence
Study design
Randomized trial at 51 centers, mostly in Australia or New Zealand.
Enrollment
1,600
Follow-up
All-cause mortality within 90 days after randomization.
Geography
Australia, New Zealand
Clinical question
Does EGDT reduce 90-day mortality compared with usual care in early septic shock presenting to the emergency department?
Population
- Patients presenting to the emergency department with early septic shock.
Intervention
Early goal-directed therapy.
Comparator
Usual care.
Primary outcome
All-cause mortality within 90 days after randomization.
EGDT did not reduce 90-day all-cause mortality compared with usual care in early septic shock.
Absolute risk difference / -0.3 / 95% CI -4.1 to 3.6 / p=0.90
Key results
- 90-day mortality: 18.6% with EGDT vs 18.8% with usual care; absolute risk difference -0.3 percentage points (95% CI -4.1 to 3.6; p=0.90).
- In the first 6 hours, the EGDT group received more intravenous fluid (1964±1415 ml vs 1713±1401 ml).
- EGDT patients were more likely to receive vasopressors (66.6% vs 57.8%), red-cell transfusion (13.6% vs 7.0%), and dobutamine (15.4% vs 2.6%).
- Survival time, in-hospital mortality, duration of organ support, and hospital length of stay did not differ.
Harms
- EGDT increased early use of vasopressors, red-cell transfusion, and dobutamine without a survival benefit.
Clinical Use
Practice impact
- Supports timely septic-shock care without a mandatory EGDT protocol.
Applicability
- Most applicable to emergency-department patients with early septic shock treated in systems similar to the participating Australasian centers.
Limitations
- Usual care already reflected contemporary sepsis resuscitation, so the trial tested an incremental protocol rather than resuscitation versus no resuscitation.
- EGDT increased treatment intensity in the first 6 hours without changing organ-support duration or hospital stay.
Common misinterpretations
- ARISE refutes the mandatory EGDT bundle, not the value of early recognition, antibiotics, fluids, and source control.
- A negative result means usual care matched EGDT, not that septic-shock resuscitation is unimportant.
Citation
ARISE Investigators, ANZICS Clinical Trials Group, Peake SL, et al. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014;371(16):1496-1506. doi:10.1056/NEJMoa1404380
In critically ill patients presenting to the emergency department with early septic shock, EGDT did not reduce all-cause mortality at 90 days.
- PMID
- 25272316