ProCESS (septic shock)
Trial question
What is the role of protocol-based care in patients with early septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 1341
1341 patients (593 female, 748 male).
Inclusion criteria: patients in whom septic shock was diagnosed in the emergency department.
Key exclusion criteria: required immediate surgery; active gastrointestinal bleeding; contraindication to central venous catheter placement; acute coronary syndrome; major cardiac arrhythmia; seizure; acute pulmonary edema.
Interventions
N=885 protocol-based therapy (protocol-based early goal-directed therapy or protocol-based standard therapy).
N=456 usual care (directed by bedside providers).
Primary outcome
In-hospital death at 60 days
19.5%
18.9%
19.5 %
14.6 %
9.8 %
4.9 %
0.0 %
Protocol-based
therapy
Usual
care
No significant
difference ↔
No significant difference in in-hospital death at 60 days (19.5% vs. 18.9%; RR 1.04, 95% CI 0.82 to 1.31).
Safety outcomes
No significant difference in potentially serious adverse events (excluding death).
Conclusion
In patients in whom septic shock was diagnosed in the emergency department, protocol-based therapy was not superior to usual care with respect to a in-hospital death at 60 days.
Reference
ProCESS Investigators, Yealy DM, Kellum JA et al. A randomized trial of protocol-based care for early septic shock. N Engl J Med. 2014 May 1;370(18):1683-93.
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