McGowan Institute for Regenerative Medicine
affiliated faculty member Derek Angus, MD, MPH, FRCP, FCCM, FCCP (pictured), professor and chair of the Department of Critical Care Medicine and director of CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illnesses) Center at the University of Pittsburgh, is the principal investigator on the Protocolized Care for Early Septic Shock (ProCESS) study. The project attempts 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.
One of the major challenges is to recognize sepsis when it starts. That’s because in its early stages, it is often mistaken for a milder infection or other problems, said Dr. Angus. "A person may arrive with what looks like a simple case of pneumonia, and the emergency department team starts antibiotics and believes things will go well. Only when the blood pressure drops or is no longer responsive to intravenous fluids does the team realize it is suddenly behind the eight ball. By then, the patient is quickly spiraling into multisystem organ failure. Starting resuscitation at this point may already be too late."
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, being conducted at several leading hospitals around the country, is enrolling 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 6 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.
“Septic events trigger such huge responses in the body that the clock sometimes doesn’t reset properly,” Dr. Angus says. For example, sepsis patients may go home from the hospital appearing to have recovered, “but a significant portion still have some inflammation under the surface and are more likely to be in trouble in the coming months,” especially older patients, he says.
“We are seeing some improvements in short-term mortality but we may be creating a second problem of having an ever-expanding population of sepsis survivors,” Dr. Angus adds. “It’s not enough to have people not die — we really need to think about how we help people recover from sepsis.”
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.
Illustration: McGowan Institute for Regenerative Medicine.
The Wall Street Journal (09/13/11)
The Wall Street Journal (09/13/11)
National Institute of General Medical Sciences News Release (10/02/06)
Protocolized Care for Early Septic Shock website
Bio: Dr. Derek Angus