Are State Rules For Treating Sepsis Really Saving Lives?

May 30, 2017
Originally published on May 30, 2017 7:21 pm

Doctors can save thousands of lives a year if they act promptly to identify sepsis, an often lethal reaction to infection. Sometimes called blood poisoning, sepsis is the leading cause of death in hospitals.

A 4-year-old regulation in New York state compels doctors and hospitals to follow a certain protocol, involving a big dose of antibiotics and intravenous fluids. It's far from perfect — about a quarter of patients still die from sepsis. But early intervention is helping.

"Intervention has to be quick," says Dr. Howard Zucker, commissioner of the New York State Health Department.

He knows what happens when it isn't. In fact, he says, he has a cousin in the hospital right now who has been struggling to recover from a severe bout of sepsis — hospitalized in another state, he adds.

Doctors didn't immediately realize that he was developing sepsis, and by the time they did, Zucker says it was much more difficult to treat. "That's what we're trying to do. We want people to intervene quickly. That's the regulation, to intervene fast in a situation of this nature."

Indeed, sepsis death rates in hospitals have declined where these rules are in place.

But Dr. Jeremy Kahn at the University of Pittsburgh has mixed feelings about these regulations.

"If we [doctors] were great at doing the right thing — the thing that most people agree on — then we wouldn't need regulation," he says. But in reality, doctors don't all keep up with the latest best practices and follow them, Kahn says, so regulations save lives.

"The downside is that a regulatory approach lacks flexibility," he adds. "It essentially is saying we can take a one-size-fits-all approach to treating a complex disease like sepsis."

That's problematic, because doctors haven't found the best way to treat this condition. The scientific evidence is evolving rapidly, Kahn says. "Almost every day another study is released that shows what we thought to be best practice might not be best practice."

Kahn wrote a commentary about the rapid changes earlier this month for the New England Journal of Medicine.

For a while, medical practice guidelines distributed to doctors called on them to use one particular drug to treat sepsis. It turned out that drug did more harm than good. Another heavily promoted strategy, called goal-directed therapy, also turned out to be ineffective.

And a study presented last week at the American Thoracic Society and published electronically in the New England Journal of Medicine finds that one of the steps required in New York may not be beneficial, either.

The regulations call for a rapid and substantial infusion of intravenous fluids, but that didn't improve survival in New York state hospitals.

Many doctors consider fluids helpful, but "what we haven't learned is the specific type of fluid to give patients, how much and how fast of a rate," says Dr. Christopher Seymour, a critical care researcher at the University of Pittsburgh who co-authored the analysis. "It's been quite controversial."

"There are consequences and adverse effects that can come from too much fluid," Seymour says.

In fact, some doctors believe that most patients are better off without this aggressive fluid treatment. There's a study getting underway to answer that question. Dr. Nathan Shapiro at Harvard's Beth Israel Deaconess Medical Center hopes to enlist more than 2,000 patients at about 50 hospitals to answer this life-or-death question.

But that study will take years, and in the meantime doctors have to make a judgment call.

"It is possible that at present they are requiring hospitals to adopt protocols for fluid resuscitation that might not be entirely appropriate," Kahn says.

There could also be other big changes on the horizon for treating sepsis.

Doctors scattered coast to coast are trying a new protocol that, in addition to limiting fluids, uses high doses of intravenous vitamin C, steroids and vitamin B1. That has generated a great deal of enthusiasm and some startling claims of success, though it remains to be seen whether it is indeed an exciting advance or will become another disappointment in treating sepsis.

Dr. Zucker at the New York Health Department says the current regulations would not stand in the way of advances to treatment.

"If there is a disruptive technology that comes out, or a therapy that comes out, we would adjust accordingly."

You can reach Richard Harris at rharris@npr.org.

Copyright 2017 NPR. To see more, visit http://www.npr.org/.

ARI SHAPIRO, HOST:

Sepsis is the leading cause of death in hospitals. It's a reaction to infection. Sometimes it's called blood poisoning. People who get fast and aggressive treatment are more likely to survive. That observation has prompted a few states to require specific steps for the condition, but those guidelines may not dictate the best possible treatment. NPR's Richard Harris reports.

RICHARD HARRIS, BYLINE: Treating a complicated condition like sepsis is, well, complicated. So doctors and medical societies develop guidelines to help highlight the current consensus. In 2013, New York state turned those voluntary guidelines into actual regulations that doctors must follow. Howard Zucker, commissioner of the New York State Health Department, says one point is key.

HOWARD ZUCKER: Intervention has to be quick.

HARRIS: Antibiotics and fluids are given at the first signs of trouble. Dr. Zucker knows what happens when that doesn't happen. In fact, he says, he has a cousin who has been struggling to recover from a severe bout of sepsis - hospitalized in another state, he adds.

ZUCKER: The health officials didn't ask the question, could this be sepsis? And then as the hours ticked by and symptoms progressed, then suddenly it was, oh, maybe this is sepsis. That's what we're trying to address. We want to have people intervene quickly. That's the regulations.

HARRIS: Early intervention is saving lives, though sepsis still kills about a quarter of the people who develop a serious case. And Dr. Jeremy Kahn at the University of Pittsburgh has mixed feelings about regulations. On the plus side, they do encourage doctors to act.

JEREMY KAHN: If we were great at doing the right thing, the thing that most people agree on, then we wouldn't need regulation.

HARRIS: But Kahn says doctors don't all keep up with the latest, best practices and follow them.

KAHN: The downside is that a regulatory approach lacks flexibility, and it essentially is saying that we can take a one-size-fits-all approach to treating a complex disease like sepsis.

HARRIS: And that's a problem because doctors haven't found the best way to treat this condition.

KAHN: The evidence is not only not ironclad, but it's rapidly shifting. Almost every day, there's - a new study is released that shows that what we thought to be best practice might not be best practice.

HARRIS: For a while, the practice guidelines called on doctors to use one particular drug to treat sepsis. It turned out that drug did more harm than good. And now a study presented at the American Thoracic Society and published in The New England Journal of Medicine finds that one of the required steps in New York may not in fact be beneficial. Christopher Seymour, a critical care physician at the University of Pittsburgh, says this has to do with intravenous fluids. The current regulations call for a rapid and substantial infusion.

CHRISTOPHER SEYMOUR: But what we haven't learned is the specific type of fluid to give patients, how much and how fast of a rate. And it's been quite controversial.

HARRIS: Seymour's data, based on the experience in New York state since the new regulations took effect, found that an early dose of fluids didn't actually help.

SEYMOUR: There are consequences and adverse effects that can come from too much fluid. And as a result, there's been great interest in this early phase of care and understanding the timing and the volume.

HARRIS: In fact, some doctors believe that most patients would be better off without this aggressive fluid treatment. There's a study getting under way to answer that question, but that will take years. So right now, it's a judgment call, Kahn says.

KAHN: So it is possible that at present they are requiring hospitals to adopt protocols for fluid resuscitation that might not be entirely appropriate.

HARRIS: It's also possible that there are other big changes on the horizon for treating sepsis. Doctors scattered coast to coast are trying a new protocol that, in addition to limiting fluids, uses high doses of vitamin C, steroids and vitamin B1. that has generated a great deal of enthusiasm. It remains to be seen if it is indeed an exciting advance or another disappointment.

ZUCKER: If there is a disruptive technology that comes out or a therapy that comes out, we would adjust accordingly.

HARRIS: Zucker at the New York State Health Department says the current regulations would not stand in the way. Richard Harris, NPR News. Transcript provided by NPR, Copyright NPR.