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evident

ARISE

Goal-directed resuscitation for patients with early septic shock

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.