Survival of patients with septic shock was the same regardless of whether they received treatment based on specific protocols or the usual high-level standard of care, according to a five-year clinical study.
The large-scale randomized trial, named ProCESS for Protocolized Care for Early Septic Shock, took place in 31 academic hospital EDs across the country and was funded by the National Institute of General Medical Sciences, a branch of the National Institutes of Health.
ProCESS set out to determine whether a specific protocol would increase the survival rates of people with septic shock, Sarah Dunsmore, PhD, who managed the trial for NIGMS, said in a news release. What it showed is that regardless of the method used, patient survival was essentially the same in all three treatment groups, indicating that sepsis patients in these clinical settings were receiving effective care.
Sepsis can lead to septic shock, which starves tissues of oxygen and can damage major organs. It remains frustratingly hard to identify, predict, diagnose and treat, according to the NIGMS news release. According to the CDC, sepsis affects more than 800,000 Americans annually and is the ninth-leading cause of disease-related deaths, and the Agency for Healthcare Research and Quality ranks it as the most expensive condition treated in U.S. hospitals at more than $20 billion in 2011.
Study methodology and results
The ProCESS trial, led by Derek C. Angus, MD, MPH, and Donald M. Yealy, MD, of the University of Pittsburgh, set out to test three approaches to sepsis care.
As published March 18 on the website of the New England Journal of Medicine, the trial enrolled 1,341 patients randomly divided into three groups.
Early goal-directed therapy (Group 1): Physicians inserted a central venous catheter to continuously monitor blood pressure and blood oxygen levels. For the first six hours of care, clinicians kept these levels within tightly specified ranges using intravenous fluids, cardiovascular drugs and blood transfusions. This protocol was based on a 2001 study in an urban ED that noted a striking increase in sepsis survival using this approach.
Protocolized standard care (Group 2): This alternative tested a less invasive protocol that did not require central venous catheter insertion. Physicians used standard bedside measures such as blood pressure, heart rate and clinical judgment to evaluate patient status and guide treatment decisions. Clinicians kept patient blood pressure and fluid levels within specified ranges for the first six hours of care.
Standard care (Group 3): Patients received the same high level of care they would typically get in an academic hospital ED. Clinicians did not follow specific guidelines or protocols associated with the study.
After using an array of statistical analysis tools, the ProCESS investigators concluded that the three treatment arms produced results that were essentially indistinguishable for survival at 60 days, 90 days and one year; heart and lung function; length of hospital stay; and a standardized measurement of health status at discharge.
The good news from this study is that, as long as sepsis is recognized promptly and patients are adequately treated with fluid and antibiotics, there is not a mandated need for more invasive care in all patients, Angus said in the news release.