A study led by researchers from the University of Pittsburgh School of Medicine found less technical sepsis treatments are just as effective as their more structured counterparts in battling the life-threatening condition.
Researchers looked at three existing treatments for sepsis and found no significant difference in survival rates among them. The findings come from a national, randomized clinical trial released today. The study will be published in the May 1 edition of the New England Journal of Medicine.
Sepsis is a condition where infection affects more than one organ and can cause organ failure. It can be a complication, for example, of pneumonia or an abdominal or kidney infection and is most common in elderly people and those with weakened immune systems. In septic shock, when the infection reaches the circulatory system, blood pressure drops dramatically and can lead to death.
Sepsis is treated with a combination of antibiotics, intravenous fluids and blood pressure medicines. Every year, about 750,000 cases of severe sepsis and septic shock occur in the U.S. Between 18 and 21 percent of sepsis patients die in the hospital.
"Sepsis is more deadly than a heart attack or a stroke," said Donald Yealy, investigator, professor and chair of Pitt's department of emergency medicine.
"Until 10 years ago, 40 to 50 percent of people coming into a hospital with sepsis died," Dr. Yealy said. "It didn't seem that anything mattered."
Then a 2001 "landmark trial" in Detroit found success in treating sepsis patients with a special catheter called a central line to the jugular vein to monitor blood pressure and oxygen levels, Dr. Yealy said. The treatment protocol, called "early, goal-directed therapy," or EGDT, combined the use of the catheter with a delivery of drugs, fluids and blood transfusions.
The study found using this treatment reduced patient mortality from 46 percent to 30 percent. However, the treatment was very detailed and sometimes difficult to administer.
"We wondered, could we get there in a simpler way?" Dr. Yealy said.
The new study looked at three treatment methods: the EGDT treatment used in the Detroit study; a protocolized standard care, or PSC, that was simpler than EGDT that still required vein access but no central catheter; and the usual care used in hospitals where individual physicians direct course of treatment.
Protocolized Care for Early Septic Shock, also known as ProCess, was a five-year, multicenter study funded through an $8.4 million grant from the National Institute of General Medical Sciences, part of the National Institutes of Health. Thirty-one hospitals participated, with 1,351 patients with sepsis enrolled.
Researchers found no significant difference in survival rate between the standardized protocols and the patients who received care under an individual doctor's discretion. They concluded that with early detection and vigilant care, care driven by doctors' decisions is as effective as a pre-prescribed sepsis treatment.
After 60 days, 21 percent of the EGDT group had died in the hospital, compared with 18.2 percent of the PSC group and 18.9 percent of those receiving standard care. There remained little difference in mortality after 90 days or one year.
Dr. Yealy said the recent study refined the thinking of the 2001 study. For all sepsis treatment, "early treatment and recognition is crucial," he said.
"Sepsis is easy to miss," he said. "There is no one signal or test for sepsis," unlike heart attacks or strokes.
"Many organizations have endorsed structured guidelines for treatment that often call for invasive devices early in care," said study investigator Derek Angus, department chair of critical care medicine at Pitt, in the news release about the study. "But with prompt recognition and treatment of the condition, we found that these approaches do not improve outcomes but do increase use of hospital resources."
One of the 31 hospitals was Allegheny General Hospital, which enrolled 16 patients between April 2011 and June 2013. Arvind Venkat, site principal investigator for the trial and director of research in the department of emergency medicine at Allegheny Health Network, said the treatment of sepsis "is a huge issue in emergency medicine."
"For us in emergency medicine, it makes a big difference," Dr. Venkat said.
"You want to do well by all patients. Knowing what are necessary things to do, and know what's extraneous matters to how efficiently and well we can treat patients."
Though much has changed since the 2001 study, for Dr. Yealy, a mortality rate around 20 percent is still too high.
"It's a deadly disease," he said. "But it's a dramatic improvement over a decade ago. That's the silver lining."
Lauren Lindstrom: firstname.lastname@example.org or 412-263-1964.