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.

Skeptics have argued that there haven’t been any comprehensive studies to support the notion that the protocols can actually save lives.

On Sunday, however, the New England Journal of Medicine published a large study 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 percent and 4 percent.

“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 Center, who led the study. “It can be lifesaving.”

Talia Bronshtein/STAT Source: The New England Journal of Medicine

Dr. Steven Q. Simpson, who leads critical care medicine at the University of Kansas Medical Center, and who was not involved in the study, said 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 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 percent to 15 percent, according to the new study. For a 70-year-old with more than one serious illness, the risk of death increases from 29 percent to 38 percent.

Sepsis is a life-threatening illness that often occurs in people who are hospitalized. Here's how it works. Dom Smith/STAT

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 percent and 70 percent of the time.

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 judgment with patients; others feel the protocols further deepens an emerging medical crisis around the overprescribing 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 percent 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 percent.

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.”

A child’s case draws attention

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 Regulations” 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 Centers for Medicare and Medicaid Services, which oversees the nation’s government-run insurance programs, 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 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.’”

‘Hospitals are finally starting to listen’

Many family members of those who have died of sepsis say their loved ones were doomed by clinicians who were overworked or negligent, or whose judgment was simply clouded with hubris.

Lisa Bartlett Davis lost her husband Jeff in 2012, roughly 24 hours after he checked himself into an Illinois hospital with a temperature of 104.6. He was told he had the flu and that he’d be discharged, despite his nurse’s verbal insistence that there was something else wrong.

“The doctor just blew her off,” Davis said.

After a shift change the next morning, her husband was in agony from the spreading infection. His blood pressure skyrocketed and a new doctor ordered tests of his spinal fluid. But Davis entered septic shock and died shortly after being transported to another hospital.

“We never found out the cause of the infection,” she said. “I still don’t know.”

Debbie Shearer’s son, George, faced even more troubling issues with his medical staff in Florida in early 2006 when he was recovering from surgeries following a car accident.

Hospital staff insisted that the 20-year-old shower, despite recovering from a craniotomy he had undergone to relieve pressure in his brain. Another staff person insisted on changing bandages on his legs as he sat on a toilet. When he started showing major signs of infection the next day – his legs turned black, among other symptoms – staff ignored the symptoms.

He languished for days in that hospital and in a subsequent rehabilitation facility before EMTs urged his mother to transport him to an acute care facility and an ICU. By the time he got there, his organs were failing. He later died.

“When I tried to explain to my dearest friends what happened, they said ‘Are you sure?’ There’s no way this could happen in our country,’” she said.

“Now I feel like hospitals are finally starting to listen, and realizing that not only does it help to save lives if you have protocols — because every minute counts, as we know —but it also saves on health care costs,” she said.

If researchers quibble with the timing threshold at which sepsis-prevention protocols should be mandated, Simpson said, patient stories like these reveal the wisdom of at least attempting quick responses.

“There’s nothing wrong with shooting for shorter, but it’s clearly a mistake to shoot for longer,” he said. “Because whatever goal you set, you’re going to miss sometimes. Look at this as if you’re a patient. Or it’s your mom and dad.”

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  • I want to commend this site for allowing unaltered comments! I share my experiences in hopes of helping others and although it’s harder for me to communicate clearly, I do appreciate the opportunity to do so freely. I’m still here : ) Sepsis is treated with IV vancomycin, the antibiotic of last resort, the big gun. In part because there is no time to wait on test results. I suspect most infections are not sudden, but a sudden progression of a stealth infection(s). A link that needs to be strengthened in our medical system is improved testing. And a willingness to keep testing until an answer is found. Patients are routinely told that their afflictions are normal. Suffering and dying of infection, without diagnosis, is apparently normal. Suffering in unbearable pain is increasing with the restriction of opioids. The definition of sepsis was recently changed to describe the body’s reaction to dying in shock. In the past it was defined as an infection. There is a shift happening to downplay the need to identify pathogens in illness. This is a barbaric approach to medicine. Not only can you not treat optimally, most doctors won’t prescribe any antibiotics without a clearly identified pathogen, so there is no treatment. Sepsis is on the rise. More people die of sepsis than from AIDS. and from cancer. Combined. This article seems to be quoting lower numbers then I’ve found in my studies. About 1/3 of people who get sepsis die of it, not just immediately but because it can linger unrecognized. While MERSA gets the attention as a reason to be careful of superbugs, the leading pathogen for sepsis is Strep. Strep B is the UTI strain rather than throat. Either can progress to the heart as rheumatic fever and I’m guessing a lot more people die this way then we know. At this stage is difficult to diagnose or treat and usually is not. The key is to treat at first presentation during childhood. I think we have a lot of young parents not taking strep throat seriously because we are busy, but take note because untreated strep can make for big, undetected problems later. Of note is the new trend to test and treat birthing mothers for GBS. Please DO. GBS (strep B) is more than just the most common pathogen of mortality for babies, it is of the elderly, and increasingly the middle aged. It is the grim reaper that strikes when you’re bedridden from another illness. We don’t look sick until it’s too late, so take a page from the Velvetine Rabbit and take the streps seriously as if there may not be a second chance to do so.
    After being treated for sepsis, a potential caretaker told me it sounded like I had Lyme as an underlying disease. But I had asked so many doctors about Lyme and they all said it couldn’t be. This is what people should know about the controversy of Lyme. It’s very common. If you have pain, neuro sx and/or fatigue, think Lyme and see an LLMD. There are no Lyme doctors in your medical plan and no doctors willing to refer you. Briefly, the tests only work within a few months of being bit, but most people don’t know they contracted it. The documentary Under Our Skin is eye opening- at least watch the trailer on Amazon please.
    Treatment on top of illness is Brutal. But A few months in to my Lyme treatment last year something miraculous happened. The decades of pain caused by infection resolved. I was opioid free after decades of dependency. I’m ill still, but better. Every morning I still feel like I’m dying but it gets better through the day. Always return to bed for rest still, but was able to fix up my house this year and bring in a roommate- another Big Miracle. To do so, I had to suspend the antibiotics to function. Tough choices. I’m too ill to also fight for SSDI. My main infection is Bartonella/cat scratch fever. We have a broken medical system and the missing link is testing for pathogens and treating them. The answer IMO does not lie in expecting change from doctors. Their hands are rather tied because the insurance co’s will always follow the money. And there is no money in treating with antibiotics. The solution happens one informed consumer at a time. There are going to be more companies bringing testing to the markets that patients can access better. Medical Tourism saved me. Think outside the box. Self refer to private doctors who practice antibiotics, stem cell, and/or functional medicine. When there are more of us standing together out here and raising awareness, THEN the system will learn it needs to do so too in order to keep members. It will happen in time. Thanks for reading and good luck to you and yours!

  • My sister contracted sepsis while being treated at a rehabilitation center in Colorado. My sister is 53 years old living with chronic rheumatoid arthritis, she was admitted to this facility to help with weight gain, strength and mobility. Prior to her admittance, my sister was able to walk, sit, move her hands and arms. She went from being mobile, to immobile. She contracted an infection due to a wound near her buttocks in which the facility caregivers failed to properly clean after each bowel movement. She then came down with a fever of 104° everything went down hill from there, she had a serious UTI, blood pressure was severely low, she was going in and out of consciousness. She was admitted to the hospital for further treatment, but the hospital never diagnosed her with sepsis even though I begged them to check for it. My sister is critical condition and is fighting for her life as I am writing this. I wish all Colorado hospitals supported the sepsis protocol. It’s very upsetting and a damn shame that this is happening… We need better healthcare protocol’s

    • Elaine, I’m so sorry. How is your sister now? I’m the LISA referenced in the article. I tried for 3 years to get mandatory sepsis protocols in CO. I had the Governor on board and the health department but the hospital association shut it down saying they could do better on their own. I told them to tell that to the family who lost their 30 year old daughter and the quad amputee that god sent home. Both from CO hospitals. Hugs to you!

    • Amen! I’ve been trying to get it passed in CO for the last 3 years, but the CO hospital association (CHA) thinks they can do better on their own…while people are still dying!

  • I am still struggling to overcome a life threatening systemic GBS bacterial infection that went septic. Dozens of incidents & overall lack of treatment have taught me that there is a huge disparity between a reasonable standard of treatment and the reality of treatment of serious bacterial infections in the US. 2 1/2 years ago I got a series of strep group B infections; UTI followed by several vaginal infect’s. Accompanied by difficulty breathing & elevated vitals. (Had previous IUD pain- seems was undetected GBS infection that spread). Yes, 47 year old’s w/o other medial problems can die of GBS. My Dr said she stood vigil while her prior patient died of this and refused to further treat me or refer me to specialists. I was caught in a nightmare, further exasperated by my brain fogged state. ER would not treat with antibiotics without tests, but wouldn’t do pap smears to get results. Obgyn wouldn’t treat with AB’s. By the skin of my teeth, I saw a dr who referred me to an ID Dr who extended my oral AB’s for 10 years. (Meanwhile another Dr said my illness wasn’t possible bc I’d be dying, and when I showed him test results he Freaked Out and submitted a false report to police because- as he said to me- He could not afford the liability of me as a patient- so his solution was to falsely call me a criminal- so left field)… The oral antibiotic medication was not enough & I lay bedridden for 18 months in pain, illness and fatigue… until I spiked a 106 fever. Following 12 months of monthly ambulance calls for heart failure sx, I finally was recognized with sepsis, and images showed endocarditis fluid infection around my heart. I received 1 week of a standard 4-6 week sepsis/endo treatment. My vitals dropped from too high to too low. But I felt a world better and the heart infection cleared. Still, I was released & basically sent home to die with shaking heads. I am so grateful for the life saving IVA’s, but was surprised to find that the final diagnosis (in addition to sepsis and endocarditis) was ‘drug fever’ from “too much” antibiotics. I can’t even breathe without steady oral antibiotics and I doubt I’ll recover without more IVab’s. I feel so helpless bc I know from several sips of IV AB’s that they work & that I’d be healed by now if I had adequate access. My Dr’s tell me I’m dying of ‘natural causes’. That may be true, but it’s not well. I’ve been told Many times that Dr’s are saving the IVAB’s for those who are dying. But I know first hand that it’s a crap shoot as to whether we actually get the treatment that is presumably reserved for us. Why make the goal to revive almost-corpses, rather than treat infections fully at the time of initial presentation? Meanwhile farm animals are getting 5x the AB’s per pound as people?? Bacteria have been, and will be, everywhere forever. I’ve had so many tests ‘misplaced’ and been denied treatment due to ‘”false positives”. I think it feels like a difficult maze because it is set up that way by the medical plans who have Dr’s work hard at not acknowledging the need for an expensive IVAB treatment. I even resorted to vet supply shots of penicillin. We need to get better at using AB’s rather than go to lengths to avoid administering them. AB’s are one of our society’s most precious scarce resources. We need to use them optimally; not just to reduce mortality, but to avoid morbidity. It’s all I can do to not voluntarily ‘check out’. If I had the choice, I would sign away my rights to fight of MERSA in my 70’s, just for the hope of not being bedridden while my organs are slowly destroyed today. I have spent alot of time too ill to convey my story. I post this, not just for me, but for my fellow souls who have suffered similar journeys. Let’s keep learning and bettering health care.

  • This is truly the era of misinformation. Algorithmic protocols for sepsis have been the standard of care in the US for sepsis since 2000 in the both the emergency room and intensive care units. Sepsis protocols are part of medicare’s requirements for hospital base reimbursement for the past 10 years. Are these authors from an alternative reality?

    • These authors are not from a virtual reality. I lost a brother in 2006, a brother-in-law a few years later, and my daughter-in-law lost her mother two years ago. All three died from Sepsis. I have an infection right now. I have been fighting this infection for seven weeks, fighting with antibiotics and hoping I’m not going to lose my leg or life. Hospital Emergency Room doctors and the lack of culturing, caring and following protocol is the problem. I have insurance and I’ve spent thousands of dollars fighting this overlooked infection. In the last year I lost the two crowns a local dentist applied from an infection because he didn’t give me an antibiotic when I asked for antibiotic. I worked in the operating room in several hospitals. We have a crisis in this country and people are dying!

    • Sepsis protocols work if they are followed but not all hospitals are following them! My husband arrived in early sepsis with 3 SIRS symptoms yet he was misdiagnosed with the flu for 7 hours until he went into septic shock. 16 hours later he was dead. We had a 9 month old lil girl and a 3 year old lil boy. Jeff was 40 years old. This shouldn’t be happening!

    • Very few hospitals are using algorithms in sepsis diagnosis. Sepsis is missed about 50% of the time in the US. Even if protocols are in place they are often not being followed. This was my husband referenced in this article. He arrived at the hospital in early sepsis missed by 2 different ED Dr.

  • I was released just yesterday after a weeks stay in an acute hospital. My diagnosis was Sepsis. This is my 2nd confirmed Sepsis infection in 2 years. We don’t know why I’ve twice been hospitalized for it. The 1st stay was a month as an inpatient. I’d love to see this protocol put in place in all acute care facilities.

  • There was a very good article on Guidelines in the early 2000’s. It went over the concepts of Foresighted Practice Guidelines versus Hindsighted practice guidelines. Physicians have to foresight problems, health care issues with patients. Once the diagnosis is know, the therapies are well known. However, this is hindsighted. When a patient comes to the hospital, the physician does not know the diagnosis, and it takes time to get to that most important decision making. Remember, every patient with fibrocystic lung disease, is diagnosed as an “Asthma” patient for the first few years. Because for the first few years, the symptoms and clinical findings appear the same.
    Thus, this article on Foresighted Practice Guidelines made a point of excellence, Physicians use a top down approach when trying to discover the true diagnosis of the illness of any given patient. The arm chaired generals have to better understand process, for the hindsighted practice guidelines are completely inappropriate and they may increase the morbidity and mortality, if one starts therapy for the wrong diagnosis. I wish I could remember where the article was printed, it was one of the few process articles in health care, and it was spot on.

  • Stanford Hospital saved my Mother’s life after another urgent care facility was going to allow her to go home. It is precisely because they followed these protocols in the emergency room that she is still alive. I am so grateful for that!!!

  • An example of a common error among journalists: calling nursing practice “hospitals.” Hospitals are buildings. NURSES note the early signs of sepsis, alert colleagues such as physicians or other prescribers, and NURSES save lives this way. Hospitals don’t do that.

    • Agreed, nurses detect sepsis. However, a very smart and attentive RN was with my father the day he slipped into septic shock, and she mistook his symptoms as fatigue. The signs can be very vague. I insisted that she check his vital signs. When there is known infection and the patient becomes groggy or not quite as responsive as they had been previously, they should check for sepsis. This time, it was a nurse that detected it (ME) but that day I wasn’t a nurse, I was a daughter. So, it is very important to always listen to the patient’s family when they detect a change in their loved one…they know them much better than anyone at the hospital or other clinical setting.

  • Alvin – this is dangerously deluded nonsense. You clearly know nothing about sepsis and there is no evidence of benefit for cannabis or cannabis oil for any medical condition. You’re exhibiting the Dunning-Kruger effect.

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