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Protocolized Care for Early Septic Shock (ProCESS)

Protocolized Care for Early Septic Shock (ProCESS) 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.

This multicenter research consortium is undertaking a large-scale study to determine whether specific interventions can halt the progression to severe sepsis and septic shock. Key to the project is determining whether there are "golden hours" during which prompt, rigorous, standardized care can save patients' lives. The project may establish the first set of standard procedures to diagnose and treat sepsis in emergency departments.

The National Institute of General Medical Sciences (NIGMS), part of the National Institutes of Health, launched the project with a grant totaling more than $8.4 million over five years. Derek C. Angus, MD, and Donald Yealy, MD, of the University of Pittsburgh School of Medicine, lead the consortium, which is a partnership between physicians in emergency medicine and those in critical care medicine. "By improving the treatment of those critically ill with sepsis, the consortium's work will have enormous implications for the public health of the country," said former NIH Director Elias A. Zerhouni, MD.

Every year, sepsis affects more than 700,000 Americans. About 30 percent of them die. Sepsis occurs when the body's normal reaction to an infection goes into overdrive, causing widespread inflammation and dramatic changes in body temperature, blood pressure, breathing, and heart rate. It can lead to the malfunction or failure of several major organs.

"The goal of this project is to speed recovery, increase survival rates, and improve the long-term quality of life for those who have had sepsis," said NIGMS Director Jeremy M. Berg, PhD.

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 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."

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