![ 60-day mortality did not differ among the three
groups
◦ 21% in EGDT,
◦ 18% in protocol-based standard care,
◦ 19% in usual care;
95% confidence interval [CI], 0.82 to 1.31; p=0.83), with
comparably insignificant differences in 90-day and 1-year
mortality rates.
Primary outcome](https://image.slidesharecdn.com/process2-150309140913-conversion-gate01/85/PROCESS-trial-16-320.jpg)
PROCESS trial
- 1. Protocolized Care for Early Septic Shock
- 6. The physicians say it happens in hectic fever, that in the beginning of the malady it is easy to cure but difficult to detect, but in the course of time, not having been either detected or treated in the beginning, it becomes easy to detect but difficult to cure.” Machiavelli – The Prince Chapter 3
- 7. Early Goal Directed Therapy (EGDT), 6 hour protocol invasive measurements of hemodynamics to guide resuscitation New era of sepsis management Rivers et al (2001)
- 10. Protocol-based approach in treating sepsis 1341 patients in suspected septic shock 31 centers, Randomized in a 1:1:1 ratio Protocol-based EGDT, Protocol-based standard care Usual care within 2 hours of recognition of shock and within 12 hours of arrival to the ED Process-trial
- 11. Central venous catheter placement Treated based on targets in Rivers’ algorithm: ◦ central venous pressure, ◦ mean arterial pressure, and ◦ mixed venous oxygen saturation. The amount and timing of volume resuscitation was specifically dictated in this treatment group. EGDT
- 12. Through a review of the literature Input of expert physicians, Targets requiring less invasive measurement techniques, ◦ systolic blood pressure ◦ clinical and laboratory signs of hypoperfusion. Protocol-based standard therapy
- 13. Care without any direction from study coordinators Usual care group •Early treatment with antimicrobial agents, •conservative transfusion thresholds, •low tidal-volume ventilation •moderate glycemic control.
- 16. 60-day mortality did not differ among the three groups ◦ 21% in EGDT, ◦ 18% in protocol-based standard care, ◦ 19% in usual care; 95% confidence interval [CI], 0.82 to 1.31; p=0.83), with comparably insignificant differences in 90-day and 1-year mortality rates. Primary outcome
- 17. despite its widespread use, a protocol based on invasive hemodynamic monitoring does not significantly improve outcomes in septic shock compared to less invasive approaches. Relevance
- 18. ... is similar to research that found the use of pulmonary artery catheters did not improve mortality, ... suggests invasive hemodynamic monitoring is not a requirement for the management of septic shock. ... Can change current standards of care and management? This study...
- 19. Early recognition of sepsis, as well as cornerstone interventions – ◦ the rapid infusion of intravenous fluids, ◦ early broad spectrum antibiotics, ◦ prompt source control have a greater impact on survival than the use of invasive monitoring to guide such therapies. Bottom line
- 21. the early or facilitated ◦ recognition of septic shock, ◦ administration of intravenous antibiotics (76% after 3 hours, 97% after 6) were associated with rates of survival that were higher than projected and higher than predicted on the basis of scores on the Acute Physiology and Chronic Health Evaluation (APACHE) II
- 22. "A designer knows he has achieved perfection not when there is nothing left to add, but when there is nothing left to take away." - Antoine de Saint-Exupry
- 31. PAC is a diagnostic and haemodynamic monitoring tool but not a therapeutic intervention. Our review concluded that use of a PAC did not alter the mortality, general ICU or hospital LOS, or cost for adult patients in intensive care. Pulmonary artery catheters for adult patients in intensive care