In light of new data, "the National Quality Forum-endorsed measure and the International Surviving Sepsis Campaign guidelines for treatment of septic shock are going to have to be modified," says a critical care researcher.
Derek C. Angus, MD |
A long-awaited study of septic shock treatments has found that expensive and risky parts of a widely accepted resuscitation protocol now in place in many hospitals do not improve outcomes when compared with standard of care.
The study, conducted in 31 emergency departments in the U.S., over five years should result in some hospitals revising their regulations and guidelines governing sepsis care in, says lead author Derek C. Angus, MD, of the Department of Critical Care Medicine at the University of Pittsburgh and UPMC Health System.
"New York State is now demanding some regulations of its hospitals, and they're going to have to modify those," Angus said in a telephone interview this week. "The National Quality Forum-endorsed measure, and the International Surviving Sepsis Campaign guidelines are going to have to be modified as well."
He emphasized the federally funded trial, called ProCESS (Protocol-Based Care for Early Septic Shock) "does not invalidate the value of early recognition of sepsis, or the value of giving early antibiotics and fluids. Rather, he said, "What we have said is that after you recognize the patient has sepsis, and you start antibiotics, and done all these things, taken care of the A, B, and C for sepsis itself, then there's no additional value to adding D, E and F."
Craig Lilly, MD, a pulmonary medicine and critical care specialist at the University of Massachusetts Memorial Medical Center, who was not one of the trial results authors, reacted to the study. "This trial tells us that the catheter, the monitoring, the central venous pressure and looking at central venous saturation—a lot of stuff [that we do now] that's inconvenient and expensive—doesn't lead to better outcomes."
"With these catheters, when you put them in, there's patient risk (of infection), and it would lower cost to not put them in. So that's really what agencies like the National Quality Forum and others should be focusing on," Lilly says.
Septic shock and severe sepsis affect 750,000 patients in the U.S. a year and results in death for 15,000. It is increasingly the focus of hospital interventions because of its debilitating consequences and high 30-day and 60-day mortality rates.
Sepsis also has received increased attention because of media coverage surrounding the death of 12-year-old Rory Staunton in April 2012. Staunton sought care at NYU Langone for a cut on his arm after playing basketball. Emergency department clinicians failed to detect a telltale lab result and other symptoms of sepsis and sent him home.
Because of that, Angus says, clinicians and researchers have been passionate about doing something about septic shock. But they have vehemently disagreed on what should be done to correctly manage the condition when patients show up in the emergency department.
"Some people have said you can't possibly believe the Rivers study until it's been validated in a multicenter study, and until then we just have to put the brakes on. While others say [the Rivers study] is far too important of a study. We just have to move ahead, because these people are gravely ill; their [lives are] at stake," Angus says.
The ProCESS report is published in the March 18 online issue of the New England Journal of Medicine in conjunction with Angus's presentation of its results at the International Symposium on Intensive Care and Emergency Medicine in Brussels Tuesday.
The protocol it examines was developed a decade ago by Emanuel Rivers, MD, senior staff attending physician in the surgical critical care unit and emergency department at Henry Ford Hospital in Detroit, who had tested his theory there. His protocol—he is listed as the measure steward—was endorsed and validated by the National Quality Forum in October, 2012.
Several smaller subsequent studies suggested that some of the ingredients in Rivers' protocol were not helpful, and several professional groups in critical care medicine wrote letters to the NQF to request reconsideration. They included the American College of Chest Physicians, the Greater New York Hospital Association, the Midwest Critical Care Collaborative, the Society for Academic Emergency Medicine, and the Society of Hospital Medicine.
"They said, 'You know, that fancy-dancy expensive catheter that you stick in people, maybe you can get along without that. You don't need to be doing that,'" Lilly explains. "But the NQF in June of 2013 said they were doing what they're doing, and were going to wait for more data to come out. Well this is the data they are waiting for."
Should guidelines be revised to emphasize lower-cost less-aggressive treatment, the move could have a financial impact on hospitals and payers.
Objections were expressed by the Infectious Diseases Society of America, Henry Ford Health System, Kaiser Permanente, North Shore LIJ Health System and the Institute for Healthcare Improvement.
Now, Lilly says, "when they re-examine the data, with lots of important expert opinions and these clinical trial findings, you know that some updating is going to be required," Lilly says.
The NQF issued this statement when reached for comment Tuesday: "NQF's Patient Safety Measures Standing Committee is empanelled and will conduct an ad hoc review of this measure as a result of this newly published study at its April 17−18 meeting."
Under contract with the Centers for Medicare & Medicaid Services, the NQF has endorsed more than 700 measures of care, which guide how physicians and others treat patients both in hospital and ambulatory care settings.
The new ProCESS trial divided patients with septic shock who came to emergency departments of 31 hospitals into three groups to receive:
- Protocol-based early-goal directed therapy (EGDT),
- Protocol-based standard therapy, or
- Usual care
The outcome measure was death from any cause in the hospital within 60 days or death from any cause at 90 days, and cumulative mortality at 90 days and one year.
When the data was unlocked, the 60-day death rates were as follows: 21% of patients in the EGDT group, 18.2% in the protocol standard-therapy group and 18.9% in the usual-care group. And "there were no significant differences in 90-day mortality, one-year mortality or the need for organ support."