A structured, standardized approach to diagnose and treat sepsis in its early stages does not change survival chances for people who develop the deadly condition, according to a national, randomized clinical trial.
The findings could change the way sepsis is diagnosed and treated, researchers say. Each year, sepsis, the body’s response to severe infections, kills more people than breast cancer, prostate cancer, and HIV/AIDS combined.
“We found no overall differences in two protocolized approaches when compared to conventional treatment,” says Derek C. Angus, professor and chair of the department of critical care medicine at the University of Pittsburgh.
“The study provides strong evidence that will have immediate consequences. Many organizations have endorsed structured guidelines for sepsis treatment that often call for invasive devices early in care.
“But with prompt recognition and treatment of the condition, we found that these approaches do not improve outcomes but do increase the use of hospital resources.”
“More than 750,000 cases of severe sepsis and septic shock occur in the US each year, most receiving care initially in an emergency department. We’ve found that if early recognition and treatment happen, one approach to supporting circulation while giving antibiotics is not better than another,” says Donald Yealy, professor and chair of the department of emergency medicine.
The study “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,” says Sarah Dunsmore.
A 2001 study in a Detroit hospital suggested that early, goal-directed therapy, a treatment protocol that includes placing a catheter called a central line in the jugular vein to monitor blood pressure and oxygen levels, as well as delivery of drugs, fluids, and blood transfusions according to target levels, reduced mortality by 16 percent.
The new study, published online in the New England Journal of Medicine, tested whether EGDT was superior to either protocolized standard care (PSC), a simpler strategy that still requires vein access but no central catheter, or the usual care in hospitals across the country, in which the bedside physician directs the course of treatment.
All patients were diagnosed quickly and received prompt intravenous antibiotics and fluid resuscitation, but only EGDT required central venous catheterization, sophisticated monitoring, and blood transfusions.
Sepsis mortality rates
Between March 2008 and May 2013, 1,351 patients with septic shock at 31 US hospital emergency departments were enrolled in the trial. They were randomly chosen to receive EGDT, PSC, or usual care for the first six hours of resuscitation.
The researchers found no difference in outcomes among the three interventions: at 60 days post-intervention, 21 percent of the EGDT group, 18.2 percent of the PSC group, and 18.9 percent of the standard care group had died in the hospital. There also were no differences in mortality after 90 days or one year.
“There have been many improvements in the management of sepsis in the past decade. We examined whether giving the medical team step-by-step instructions to monitor and treat the effects of sepsis could improve survival rates as the previous study suggested,” Angus says.
“EGDT, PSC, and usual care all offer early diagnosis and methods to deliver fluids, restore blood pressure, and monitor cardiovascular function; one was not better than the other to treat the condition effectively.”
But, adds Yealy, “We are not suggesting that sepsis care should be delayed or can be limited.”
The five-year, multicenter study was sponsored by an $8.4 million grant from the National Institute of General Medical Sciences, part of the National Institutes of Health.
Source: University of Pittsburgh