"Protocol-Based Care for Early Septic Shock".The New England Journal of Medicine. Published on March 18, 2014.
Links to original sources: Wiki Journal Post Full Journal Article
Does protocol-based resuscitation improve the outcomes for patients presenting to the emergency department with septic shock?
In patients with septic shock identified in the emergency department, protocol-based resuscitation did not lead to better outcomes compared to usual care.
- 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. - The ProCESS trial aimed to determine the generalizability of these findings and if all elements of the EGDT protocol were necessary. - Findings showed no significant difference in 60-day in-hospital mortality between patients receiving protocol-based care and those receiving usual care.
- At the time of study publication, there were no updated guidelines reflecting these trial results.
- 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
- 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
- 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
- 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
- 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
- Funded by the National Institute of General Medical Sciences.
- The full text of this article is available at NEJM.org. - Supplementary Appendices include detailed study protocols, exclusion criteria, and a full list of investigators in the study.