For every hour that clinicians failed to complete the anti-sepsis protocols, known as the 'three-hour bundle' mortality rates climb by between 3% and 4%, found a large US study involving more than 49,000 patients at 149 hospitals.
Even in the face of increased pressure from regulators, many doctors have failed to fully embrace early screening and treatment protocols for sepsis, an infection-related complication that afflicts tens of thousands of Americans every year and that can be life-threatening. Sceptics have argued that there haven’t been any comprehensive studies to support the notion that the protocols can actually save lives.
However, Stat News reports, a large study has now been published that could make doctors reconsider – and help hospitals address head-on one of the most common dangers their patients face. The study, involving more than 49,000 patients at 149 hospitals in New York state, suggests that for every hour that clinicians failed to complete the anti-sepsis protocols, known as the “three-hour bundle,” mortality rates climbed by between 3% and 4%. “Our data shows that hospitals really need to do this at the outset, especially at the emergency department when they suspect sepsis,” said Dr Christopher Seymour, a critical-care specialist at the University of Pittsburgh Medical Centre, who led the study. “It can be lifesaving.”
Dr Steven Q Simpson, who leads critical care medicine at the University of Kansas Medical Centre, and who was not involved in the study, said in the report that the analysis is “especially important” because it looks at one of only two states that have essentially mandated sepsis-prevention practices. “This was every hospital in the state of New York, and they got in line with the regulations,” he said. “That is amazing.” “I hope this helps convince people to follow suit.”
The report says the protocols call on clinicians to first obtain a blood culture and measure the serum lactate level – often an indicator of septic shock, when the body’s immune system attacks vital organs – and to administer broad-spectrum antibiotics, usually by IV.
For a typical 40-year-old with septic shock, failure to follow these protocols increased the risk of death from 11% to 15%, according to the new study. For a 70-year-old with more than one serious illness, the risk of death increases from 29% to 38%.
Doctors who have already adopted the protocols and avoided treatment delays, according to proponents, have likely saved thousands of lives annually in New York alone, and could save tens of thousands nationally if the protocols are more widely adopted.
For now, though, the adoption rates remain spotty, according to Dr Sean Townsend, an intensive-care doctor and researcher at Sutter Health in Northern California. Even the best-performing hospitals in the country, he said, comply with sepsis measures between 60% and 70% of the time.
The report says doctors and administrators who resist the protocols generally cite a few concerns: They fear that strict adherence to any protocol prevents doctors from exercising their best judgement with patients; others feel the protocols further deepens an emerging medical crisis around the over-prescribing of antibiotics. Some, like Dr Mervyn Singer, professor of intensive care medicine at University College London, said that given the increase in antibiotic resistance, clinicians need more precise data about when such treatments are needed.
This study, he said, fails to provide that data.
He pointed out that while 23.6% of patients who did not complete the treatment protocols within three hours ultimately died, the proportion of patients who completed the protocols in the allotted time and also died was only marginally lower: 22.6%.
The study did not explain why some patients did not receive timely treatments, he said. But since most of the patients were elderly and possibly suffering from more than one chronic illness, he said, some may have had prolonged discussions with doctors about whether to aggressively treat a possible infection. “I think a three-hour window is reasonable for treating most cases of sepsis, and some may benefit from more aggressive antibiotic treatment, he said. “But the idea that every hour makes a difference forces doctors to think they’re racing against time. And I’d argue that that three-hour window for some patients makes no difference whatsoever.”
The report says the issue of sepsis was long ignored by many in the medical community, including in New York state. In 2012, however, a 12-year-old New York boy, Rory Staunton, died from a sepsis infection that resulted from a scrape on his arm and that was poorly managed by hospital staff. His case was later written about by New York Times columnist Jim Dwyer, and buoyed by that coverage and the attention it generated, New York state adopted “Rory’s Regulations4” the following year. The regulations made New York the first state to require that all hospitals provide early screening and documentation for sepsis, and adopt sepsis-response protocols to guide treatment – most notably, by administering antibiotics within the first hour of diagnosis.
Then, in 2015, the Centres for Medicare and Medicaid Services, which oversees the nation’s government-run insurance programmes, adopted new guidelines that compel all hospitals that accept federal funds – nearly all hospitals, that is – to track their adherence to the sepsis-management protocols. (The protocols are known as the “Severe Sepsis/Septic Shock Early Management Bundle,” or SEP-1, for short, and it largely mirrors the “three-hour bundle” protocols adopted by New York.)
Some critics point out that the protocols were instituted before a deep analysis of costs and benefits. One element of the protocols calls for rapid administration of IV fluids, for instance, and the new research shows no association between that step and lower mortality rates.
There can be significant burdens, in terms of staff responsibilities and hospital finances. Some hospitals have had to add staff to process antibiotic prescriptions more quickly, and the protocols require physicians to circle back to any patients with symptoms of sepsis.
And, the report says, sepsis is trickier to diagnose than other conditions. “Humans just like a yes or no answer, like with heart attacks: you have a test for it. Yes or no,” said Simpson, of the University of Kansas. “It’s not, ‘Well, first you have to look for abnormal vital signs, then organ dysfunction and if they’re hypotensive I’ll pay attention.’” “If it’s a little complex to diagnose, like sepsis, you can have trouble getting people to do it.”
In some environments, hospital administrators may be unwilling to devote resources to something they don’t necessarily see as a problem. Morris Miller, CEO, Xenex Disinfection Services, a San Antonio-based maker of disinfection robots, said that in recent years, hospitals have begun to respond to the issue of sepsis when faced with CMS penalties for high infection rates. But some retain attitudes similar to a hospital CEO he encountered in 2011. “I was describing the cost savings that a hospital could achieve by avoiding infections. He laughed and said ‘It’s not very flattering but we still make money even when we make people sick.’”
Abstract
Background: In 2013, New York began requiring hospitals to follow protocols for the early identification and treatment of sepsis. However, there is controversy about whether more rapid treatment of sepsis improves outcomes in patients.
Methods: We studied data from patients with sepsis and septic shock that were reported to the New York State Department of Health from April 1, 2014, to June 30, 2016. Patients had a sepsis protocol initiated within 6 hours after arrival in the emergency department and had all items in a 3-hour bundle of care for patients with sepsis (i.e., blood cultures, broad-spectrum antibiotic agents, and lactate measurement) completed within 12 hours. Multilevel models were used to assess the associations between the time until completion of the 3-hour bundle and risk-adjusted mortality. We also examined the times to the administration of antibiotics and to the completion of an initial bolus of intravenous fluid.
Results: Among 49,331 patients at 149 hospitals, 40,696 (82.5%) had the 3-hour bundle completed within 3 hours. The median time to completion of the 3-hour bundle was 1.30 hours (interquartile range, 0.65 to 2.35), the median time to the administration of antibiotics was 0.95 hours (interquartile range, 0.35 to 1.95), and the median time to completion of the fluid bolus was 2.56 hours (interquartile range, 1.33 to 4.20). Among patients who had the 3-hour bundle completed within 12 hours, a longer time to the completion of the bundle was associated with higher risk-adjusted in-hospital mortality (odds ratio, 1.04 per hour; 95% confidence interval [CI], 1.02 to 1.05; P<0.001), as was a longer time to the administration of antibiotics (odds ratio, 1.04 per hour; 95% CI, 1.03 to 1.06; P<0.001) but not a longer time to the completion of a bolus of intravenous fluids (odds ratio, 1.01 per hour; 95% CI, 0.99 to 1.02; P=0.21).
Conclusions: More rapid completion of a 3-hour bundle of sepsis care and rapid administration of antibiotics, but not rapid completion of an initial bolus of intravenous fluids, were associated with lower risk-adjusted in-hospital mortality.
Authors
Christopher W Seymour, Foster Gesten, Hallie C Prescott, Marcus E Friedrich, Theodore J Iwashyna, Gary S Phillips, Stanley Lemeshow, Tiffany Osborn, Kathleen M Terry, Mitchell M Levy
[link url="https://www.statnews.com/2017/05/21/sepsis-guidance-treatment-results/"]Stat News report[/link]
[link url="http://www.nejm.org/doi/full/10.1056/NEJMoa1703058?query=featured_home"]New England Journal of Medicine abstract[/link]