ProCESS Trial

The Article:

A Randomized Trial of Protocol-Based Care for Early Septic Shock. The ProCESS Investigators. New Engl J Med. 2014; 370:1683-1693.

The Idea:

Whether Early Goal Directed Therapy (EGDT) vs Protocol Based vs “Usual Care” influences mortality in patients with severe sepsis

The Study:

1342 Randomized patients with severe sepsis or septic shock into 3 groups (as below) at 31 academic U.S. emergency departments

1. EGDT : placement of central line for monitoring to ScVO2 and CVP, IVF, vasopressors, Dobutamine and PRBC’s

2. Protocol-based: IVF until clinically euvolemic and transfusion goal of 7.5g/dl

3. Usual Care: bedside provider judgment

The Findings:

There were no differences in mortality at 60 days, 90 days or 1 year. There were also no differences in secondary endpoints ( CV failure, Respiratory failure, Length of stay, Disposition at discharge)

The Takeaway:

Invasive protocol based treatment of sepsis including a high transfusion threshold and mandatory CVC placement for SvO2/CVP measurement do not affect mortality in severe sepsis. The most important factor is appropriate IVF resuscitation, early and appropriate antibiotics, and appropriate vasopressor administration. Please note: the “usual care” group provided aggressive and early treatment in fluids, abx, and vasopressors similar to both other groups. Usual care is not less care.