ARISE
Trial question
What is the role of early goal-directed therapy in critically ill patients with early septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.4% female
59.6% male
N = 1600
1600 patients (641 female, 950 male)
Inclusion criteria: patients presenting to the emergency department with early septic shock
Key exclusion criteria: age < 18 years, contraindication to central venous catheter insertion in the superior vena cava, contraindication to receiving blood products, hemodynamic instability due to active bleeding, underlying disease process with a life expectancy < 90 days, death deemed imminent and inevitable, confirmed or suspected pregnancy
Interventions
N=796 early goal-directed therapy (in the first 6 hour period)
N=804 standard of care (in the first 6 hour period)
Primary outcome
Death at 90 days
18.6
18.8
18.8 %
14.1 %
9.4 %
4.7 %
0.0 %
Early goal-directed therapy
Standard of care
No significant difference ↔
No significant difference in death at 90 days (18.6% vs. 18.8%; RR 0.98, 95% CI 0.8 to 1.21)
Secondary outcomes
Significant increase in median length of stay in the emergency department (hour) (1.4 hours vs. 2 hours; )
Borderline significant increase in median length of hospital stay (8.2 days vs. 8.5 days; )
No significant difference in death at 28 days (14.8% vs. 15.9%; RR 0.93, 95% CI 0.73 to 1.17)
Safety outcomes
No significant differences in ≥ 1 adverse events (7.1% vs. 5.3%, p=0.15).
Conclusion
In patients presenting to the emergency department with early septic shock, early goal-directed therapy was not superior to standard of care with respect to death at 90 days.
Reference
ARISE Investigators, ANZICS Clinical Trials Group, Peake SL et al. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506.
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