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ProCESS

"Protocol-Based Care for Early Septic Shock".The New England Journal of Medicine. Published on March 18, 2014.

Clinical Question:

Does protocol-based resuscitation improve the outcomes for patients presenting to the emergency department with septic shock?

Bottom Line:

In patients with septic shock identified in the emergency department, protocol-based resuscitation did not lead to better outcomes compared to usual care.

Major Points:

- Previous study by Rivers et al. in 2001 indicated that early goal-directed therapy (EGDT) lowered mortality in patients with severe sepsis or septic shock.

- Findings showed no significant difference in 60-day in-hospital mortality between patients receiving protocol-based care and those receiving usual care.

Guidelines:

- At the time of study publication, there were no updated guidelines reflecting these trial results.

Design:

- Multicenter, randomized, controlled trial
- N=1,341 adult patients with septic shock in emergency departments across the United States
- Interventions: Protocol-based EGDT (n=439), protocol-based standard therapy not requiring central venous catheterization or inotropes (n=446), and usual care (n=456)
- Primary endpoint: 60-day in-hospital mortality

Population:

- Inclusion Criteria: Adults with suspected sepsis, two or more SIRS criteria, refractory hypotension, or serum lactate level ≥4 mmol/L
- Exclusion Criteria: Please refer to the Methods section in the Supplementary Appendix

Interventions:

- Patients were randomized to receive 6 hours of resuscitation using one of three strategies:
1. Protocol-based EGDT, including central venous catheter to monitor pressure and ScvO2
2. Protocol-based standard therapy without requirements for central venous catheterization, inotropes, or blood transfusions
3. Usual care as determined by the treating physician

Outcomes:

- 60-day in-hospital mortality: 21.0% (EGDT), 18.2% (standard therapy), and 18.9% (usual care); no significant difference
- No significant differences in secondary outcomes including 90-day mortality, 1-year mortality, or organ support requirements

Criticisms:

- Though adherence to protocols was high, perfect adherence was not guaranteed.
- The positive effects of EGDT seen in earlier studies may not have translated into current practice due to advancements in sepsis care.
- The study cannot address whether early identification and intervention in septic shock would influence outcomes.
- The potential influence of varying practices regarding the withdrawal of care on in-hospital mortality

Funding:

- Funded by the National Institute of General Medical Sciences.