PI Derek C. Angus, M.D., M.P.H
Co-PI(s) Donald M. Yealy, M.D and Mitchell P. Fink, M.D.
Title Protocolized Care for Early Septic Shock (ProCESS)
Summary The Protocolized Care for Early Septic Shock (ProCESS) study will attempt to determine if there is a “golden hour” in the management of sepsis and septic shock when a prompt, rigorous, standardized treatment regimen can be used to improve clinical outcomes and halt the cascade of events that often lead to organ failure and death. The study takes a cue from the realm of coronary care, which has significantly reduced mortality from acute coronary diseases and dramatically reduced the costs of care by determining such best practices.
The project is designed to generate comprehensive data on the clinical and biological aspects of standardized treatment for septic shock – data that can have an immediate impact on and improve the care of the critically ill. The trial, to be conducted at several leading hospitals around the country, will enroll up to 2,000 participants who present to the emergency department with septic shock. Participants will be randomized to receive alternative treatment protocols involving intravenous fluids, drugs that reverse the shock and hemodynamic monitoring during the first six hours of care.
The protocols will be evaluated on three measures: clinical effectiveness as evidenced by improved mortality rates; effectiveness in reducing concentrations of biological markers that are associated with the four fundamental pathways of sepsis-related organ dysfunction – cellular hypoxia, oxidative stress, inflammation and coagulation/thrombosis; and cost effectiveness.
Sepsis is among the top causes of death in the United States, affecting 750,000 Americans each year, of which 30 percent die. It also is one of the most expensive diseases, with a cost to U.S. hospitals of $17 billion each year.
Source NIH/National Institute of General Medical Sciences