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Big study of sepsis is risky for patients, says consumer group trying to stop it: shots



Without a "control group" of sepsis patients receiving the usual mix of drugs and fluids, even a large study comparing two other experimental approaches will not provide helpful answers, say critics.

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Without a "control group" of sepsis patients receiving the usual mix of drugs and fluids, even a large study that compares two other experimental approaches does not provide helpful answers, say critics.

Portra Images / Getty Images

A consumer protection organization calls on federal health officials on Tuesday to discontinue a large medical study at major universities nationwide

The citizen says the study is endangering patients at risk for sepsis and at best produces confusing results

The CLOVERS trial seeks to answer a key question about sepsis, which is a common and life-threatening response to infection. Sepsis kills more than 250,000 Americans a year, often triggered by the failure of multiple organs. Since patients' blood vessels leak as a result of sepsis, it becomes difficult to maintain a safe fluid balance and blood pressure.

Doctors use a combination of IV fluids and blood pressure medications called vasopressors, such as adrenaline, to manage this life-threatening complication. But there is no consensus about the best strategy. Some doctors prefer to give a lot of fluids and use drugs sparingly; others go the other way.

"Sof trying to find the sweet spot – or the & # 39; Goldilocks Place & # 39; – is important." Craig Coopersmith, Head of the Surgical Transplant Intensive Care Unit at Emory University Hospital and an Expert on Sepsis

The CLOVERS attempt is an attempt to find this sweet spot. Patients who volunteer for the study are divided into one of two groups: you get plenty of fluids; the other gets limited fluids and more medication. Unlike most studies, this study lacks a control group – people who receive the typical amount of intravenous fluids and medications – as a comparison.

"The problem is that both experimental methods of treating sepsis can be worse," says Dr. Michael Carome, head of the Public Citizen Health Research Group, which has filed a complaint with federal health officials.

"There may be higher mortality rates for both groups compared to usual care," says Carome, and without a comparison group, there's no way to say.

And if people do better on one of these experimental treatments than those on the other, that does not mean it's better than usual care, he says. This study can not answer this question.

Carome is also alarmed that under certain unusual circumstances, the protocol requires waiting for several hours to treat dangerously low blood pressure.

"Nobody cares about a sepsis patient would normally do that as part of the usual care," he says.

The study, which was designed at Harvard and funded by the National Institutes of Health, went through several reviews from people who concluded that it was not an inappropriate risk [1965-90] Can a cocktail of vitamins and steroids Cure major killer in hospitals? “/>

"But the fact that she went through these layers of verification with these serious design flaws signals that our system for protecting human subjects is broken." Carome says.

Coopersmith, who is not involved in the CLOVERS study, reviewed the public citizen's action at the request of NPR. He does not share Carome's sense of concern.

Coopersmith agrees that including a comparison group that received the standard of care would be a better study design.

But "there is no clear standard of care for the first 24 hours," he says. Standard protocols for the treatment of sepsis only determine what doctors should do in the first six hours of treatment, while the CLOVERS study will guide treatment over a longer period of time.

He agrees with Carome that the study will not substantiate this clearly One of these experimental treatments is better than a middle ground of fluids and blood pressure medicines; so sepsis doctors will not get clear guidance from the results. But the results could help push doctors one way or the other, he says, if it helps solve the question of what's better – limited fluid or much?

Regarding concerns about how to deal with a patient with very low blood pressure, Coopersmith says, "In a very tight patient population for a tight period of time, there is a theoretical chance that someone might have what I consider to be too low Blood pressure. "

If he were involved in a doctor In this trial and with that, he says, he would depart from the protocol and treat that patient with the usual care. He expects his colleagues to do the same.

The study is not as designed as it would have been, Coopersmith says, but "he would feel comfortable taking patients into the process."

Dr. Nathan Shapiro, a professor of emergency medicine at the Beth Israel Deaconess Medical Center, Harvard, and one of the key figures in the CLOVERS study, is on hand. He refused a request for an interview, but sent a written answer to NPR.

"The study protocol was developed by experienced emergency and intensive care clinicians representing nearly 50 hospitals in the United States, following a well-accepted design." He writes.

A spokesman for the Federal Agency for the Protection of Human Research says that the bureau has not yet seen the complaint of the public citizen, but will review the allegations.

Richard Harris can be reached at rharris@npr.org .


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