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Sepsis Study Finds Same Survival Rate With Three Treatment Methods

NIH-funded clinical trial tests protocols against usual high-level care

The 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 5-year clinical study.

The large-scale randomized ProCESS (Protocolized Care for Early Septic Shock) trial was conducted at 31 academic-hospital emergency departments in the U.S. and was funded by the National Institute of General Medical Sciences (NIGMS), a component of the National Institutes of Health.

The results of the trial were published online March 18 in the New England Journal of Medicine.

“ProCESS set out to determine whether a specific protocol would increase the survival rates of people with septic shock. 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,” said trial manager Sarah Dunsmore, PhD.

According to the Centers for Disease Control and Prevention, sepsis is the most expensive condition treated in U.S. hospitals, costing more than $20 billion in 2011.

The ProCESS study tested three approaches to sepsis care. A total of 1,341 patients were randomly assigned to receive 1) early goal-directed therapy; 2) protocolized standard care; or 3) standard care.

In early goal-directed therapy, doctors inserted a central venous catheter to continuously monitor blood pressure and blood oxygen levels. For the first 6 hours of care, the doctors 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 emergency department that noted a striking increase in sepsis survival using this approach.

Protocolized standard care was a less-invasive approach that did not require the insertion of a central venous catheter. Doctors used standard bedside measures, such as blood pressure (taken using an arm cuff), heart rate, and clinical judgment, to evaluate patient status and to guide treatment decisions. The doctors kept patient blood pressure and fluid levels within specified ranges for the first 6 hours of care.

In standard care, patients received the same high level of treatment that they would typically receive in an academic-hospital emergency department. Their doctors did not follow specific guidelines or protocols associated with the study.

After using an array of statistical analysis tools, the investigators concluded that the three treatment arms produced results that were essentially indistinguishable for a range of patient outcomes. These outcomes included survival at 60 days, 90 days, and 1 year; heart and lung function; length of hospital stay; and a standardized measurement of health status at discharge.

“ProCESS helps resolve a long-standing clinical debate about how best to manage sepsis patients, particularly during the critical first few hours of treatment,” said lead investigator Donald M. Yealy, MD.

“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,” he added.

Source: NIGMS; March 18, 2014.

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