In 2001, Rivers et al. published a landmark article demonstrating an early-goal directed protocol of resuscitation that reduced mortality in septic Emergency Department patients.
Many questions have arisen throughout the years with respect to that trial; critics have complained about the overwhelming change in clinical practice based on this one single-center randomized trial.
Challenging Rivers data are the ProCESS (Protocolized Care for Early Septic Shock) investigators, who released the results from a multi-center randomized control trial of 1351 septic Emergency Department patients; the primary end-point was 60-day mortality. Click here for NEJM article.
Patients in this trial were randomized to one of three groups:
Protocol-based EGDT
Protocol-based standard (did not require central lines, inotropes, or blood transfusions
Usual care (no specific protocol; care was left to the bedside clinicians)
Bottom-line: The investigators did not find any difference in mortality between patients in the three groups and comment that the most important aspects of managing the septic patient may be prompt recognition and early treatment with IV fluids and antibiotics.
References
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