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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? “/>