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Sepsis is a medical condition caused by an overwhelming immune response to an infection. It is a major killer in both the United States and the rest of the world. Could a cheap combination of vitamins help conquer it? Several studies are underway right now to answer that question. NPR's Richard Harris reports about the push to get an answer quickly.
RICHARD HARRIS, BYLINE: Forty-four-year-old Dorian Pelfrey was desperately ill. He arrived at the Emory University Hospital in Atlanta in mid-October, urgently needing a liver transplant. Shortly after he arrived in the intensive care unit, he had a severe reaction to an internal infection, sepsis. His wife, Shauna, says his blood pressure plummeted and his heartbeat was out of whack.
SHAUNA PELFREY: He went from doing OK to just doing really bad in very little time.
HARRIS: So you must have been worried.
S. PELFREY: Yes, very, especially with trying to keep him well enough to make it to a liver transplant.
HARRIS: The doctor caring for him told Shauna that the hospital was running a clinical trial to test out an experimental treatment for sepsis. It involves IV vitamin C and another vitamin, thiamine, and a steroid. Half the volunteers would end up with the experimental treatment; the other half would get simply fluids. Everyone would get all the usual intensive medical care to treat sepsis, as well.
S. PELFREY: And I decided to enter him into the trial.
HARRIS: How'd that go?
S. PELFREY: It was a long four days of lots of medicine, lots of care from a lot of different doctors, a lot of different areas of medicine. And then he did become well enough to receive a liver transplant.
HARRIS: The Pelfreys have no idea whether he got the experimental treatment or the placebo. Regardless, Dorian's health has slowly been improving since his bout with sepsis and his liver transplant. His throat is sore because of a breathing tube, so he can't talk, but he's following our conversation from his hospital bed.
You're doing okay?
I hope you have a speedy recovery.
DORIAN PELFREY: Thank you.
HARRIS: He replies, with an almost imperceptible thank you. He is one of at least 200 people, perhaps as many as 500, who will participate in this clinical trial. It came about after a doctor in Virginia reported remarkable success with this combination of vitamins and steroids. Dr. Jonathan Sevransky, a critical care doctor at Emory, is a driving force behind the study.
JONATHAN SEVRANSKY: Hundreds of thousands of people die in the U.S. every year, and millions of people die in the world of this. So when somebody comes out with a potential treatment that is cheap and relatively easily available, it's something that you want to think about.
HARRIS: Sevransky went from thinking about it to doing it after a foundation in Atlanta approached the medical center doctors asking if they could figure out if this treatment was the real deal.
SEVRANSKY: One of the things they were very interested in doing was getting an answer quickly.
HARRIS: To accomplish that, Sevransky and colleagues at Emory, Johns Hopkins and Vanderbilt organized a clinical trial that could involve as many as 40 hospitals around the country. Now, studies with critically ill patients are challenging, in part because it's an emergency situation and doctors have to move fast. One frustrating consequence of that, Sevransky says, is that critical care is based more on tradition than carefully conducted studies.
SEVRANSKY: Back in the Dark Ages, when I was in training, almost a hundred percent of what we did was based on experience. Now probably 25 percent of what we do is based on data, and 75 percent is based on experience. And it would be awfully nice (laughter) to raise that 25 percent much higher.
HARRIS: That's part of his motivation for doing this study, which, after all, will contribute to scientific knowledge, whether the treatment is a great success, a dud or something in between. Sevransky finds that gratifying.
SEVRANSKY: And it's enjoyable to work with a team of people. You know, research is really - it's like a team sport.
HARRIS: The team include those who designed the study to make sure it provides meaningful results, those who make sure it's done ethically, another team to analyze the data and people like Dr. Kate Nugent, whose job is to make it happen day to day.
KATE NUGENT: This is some of our demo kits.
HARRIS: She reaches into the small box and pulls out vials of what may or may not be thiamine and steroids and a bottle holding about a cup of liquid that, in a real kit, might or might not be vitamin C.
NUGENT: So the full kit contains this with a kit number that's associated with it. The vitamin C needs to be stored in a refrigerator, and the thiamine and steroids can be stored at room temperature.
HARRIS: A key part of her job has been to gin up awareness and enthusiasm among the doctors who staff the various intensive care units and emergency rooms at Emory.
NUGENT: And then after patients started to get enrolling, it was kind of like a ball rolling down the hill at that point in time, and people are very excited about it.
HARRIS: To date, the trial has enrolled more than 70 patients. And the clock is ticking.
CRAIG COOPERSMITH: Getting a clinical trial done within one year, which is our goal, is actually lightning fast.
HARRIS: Dr. Craig Coopersmith at Emory says once 200 patients have been enrolled in the study, an independent group of researchers will take a peek at the data to see if there's a big difference between the patients who got the vitamins versus those who got the placebo.
COOPERSMITH: If there's a huge effect, the trial gets stopped prior to the 500 patients.
HARRIS: A huge effect would be like what the doctor in Virginia has reported in his hospital. But Coopersmith says it's much more likely that if there is an effect, it will be smaller. So the study involving 500 patients is designed to pick up a 10 percent improvement in outcomes from sepsis.
COOPERSMITH: Ten percent would be massively important. Mortality from sepsis is higher than any other condition in the hospital.
HARRIS: A 10 percent mortality decrease would save tens of thousands of lives in the U.S. every year, he says. In fact, sepsis is such a major killer, there's actually a second large study, out of Harvard, asking the same question about the vitamin treatment. The two together will either tell doctors that there's a remarkable new treatment for a deadly disease or that it was another good idea that just simply didn't pan out.
Richard Harris, NPR News.
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