ProCESS

ProCESS - Protocolized Care for Early Septic Shock - is a
multi-center trial funded by the National Institutes of Health (NIH) grant and
is coordinated by the University of Pittsburgh's Departments of Critical Care
Medicine (CCM) and Emergency Medicine.

Severe sepsis is the syndrome of acute organ dysfunction
secondary to infection. The number of Americans dying with sepsis is similar to
that of acute myocardial infarction. Sepsis affects 750,000 Americans each year
with a mortality of 30%. Despite considerable understanding of the
pathophysiology of sepsis, current efforts to improve care are hampered by
limited empiric data regarding the amount and timing of sepsis therapies.  The optimal strategy for acute resuscitation in sepsis is not clear.

To determine the optimal resuscitation strategy, the ProCESS trial will randomize approximately 2000 patients who present to the ED in septic shock to specific protocols of care (usual care, protocolized resuscitation, or early-goal directed therapy).

Subproject #1 (Clinical Efficacy)
will conduct the trial and test whether protocolized care improves mortality.

Subproject #2 (Mechanisms of Action) will measure concentrations over time of
carefully selected circulating markers of four fundamental pathways implicated
in sepsis-related organ dysfunction (cellular hypoxia, oxidative stress,
inflammation, and coagulation/thrombosis) and test whether protocolized
resuscitation reduces expression of these markers and whether the clinical
efficacy of these protocols is associated with reduced expression of these
markers.

Subproject #3 (Costs and Cost-effectiveness) will measure the costs
and resource use of protocolized resuscitation and determine the value of the
alternative strategies.