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A government critique comparing treatments for a potentially fatal disease called sepsis exposes participants to a risk of organ failure and even death, critics have accused, and should be immediately shut down.
A detailed analysis of the trial design prepared by researchers at the Clinical Center of the National Institutes of Health in Bethesda, Maryland concluded that the study "puts seriously ill patients at risk without the ability to obtain information to future patients.
In a letter to the Federal Office for the Protection of Human Research, representatives of the public health research group compared the study, called CLOVERS, to "an experiment that would be conducted on laboratory animals".
"The human subjects of the CLOVERS trial, as designed and currently conducted, are unintentional guinea pigs in a physiology experiment," wrote Dr. Michael Carome and Dr. Sidney M. Wolfe.
Launched in March, CLOVERS is funded by the NIH – despite criticism from its own investigators – and aims to enroll 2,320 patients in 44 hospitals nationwide.
During the interviews, the scientists in charge of the study defended its conception, asserting that the participants received all the care that the patients suffering from sepsis would receive normally.
"The guiding principle is patient safety, which takes precedence over everything else," said Dr. Nathan I. Shapiro, associate professor of emergency medicine at Harvard Medical School and co-chair of the study's protocol committee.
Sepsis develops when the body makes a crushing attack against an infection, causing inflammation throughout the body. He is first treated with antibiotics. If sepsis progresses, the body may experience a catastrophic cascade of changes, including blood clots and leaking blood vessels that prevent blood flow to organs.
At least 1 million Americans are diagnosed with sepsis each year, and the death rate is high: up to 30 percent succumb to the disease.
But while most adults know that they should seek immediate care for a heart attack or stroke, only half of them know that sepsis requires urgent medical attention, according to a survey conducted. by Sepsis Alliance.
Signs of sepsis include abnormally high or low temperature, underlying infection (which may not appear without blood test), signs of confusion or drowsiness and feelings of extreme illness, pain or discomfort .
CLOVERS is designed to test a new strategy for the treatment of septic shock, a dangerous fall in blood pressure that stifles blood flow to organs, affects the heart and can lead to death.
The purpose of the test is to determine whether it is best to promptly limit liquids and vasopressors – drugs that contract blood vessels – quickly, or to use more intravenous fluids and to delay blood pressure. Medication administration to patients.
The question is whether patients participating in CLOVERS receive treatment that deviates from usual care, to the point that research could put their lives at risk. Participants are only registered for 24 hours, but the first hours of treatment are essential for survival.
When patients experience septic shock, current guidelines require an increase in blood pressure by administering fluids within the first three hours of care and then administering vasopressors within the first six hours if patients do not respond to fluids.
Vasopressors may be given early, during or after the infusion of fluids; A new treatment guide for hospitals states that drugs should be used in the early hours if patients do not respond to intravenous fluids.
Many doctors have criticized rigid guidelines like this because they do not allow individualization of treatment and seem to reject the clinician's clinical judgment.
Large fluids and vasopressors can cause serious complications, but when the patient's condition continues to deteriorate, doctors use both interventions and adjust for the severity of the illness.
They usually start with fluids, which in small amounts are considered less toxic than vasopressors.
But CLOVERS participants are randomly assigned to a group of "liberal fluids" who receive large fluid infusions in a very short time, but limit the use of vasopressors or a group of "restrictive fluids" in which the .
Scientists in charge of the study note that the treatment is not difficult and fast, and insist that all participants receive medical care that "fall within the scope of usual care".
Still, they recently changed one of the treatment protocols after the study's doctors complained that its protocols were inconsistent with their practices.
The recent modification of the protocol has slowed the rapid infusion of fluids into the first group, the "liberal fluids" arm of the test. But the change could delay the administration of vasopressors in this group even when blood pressure remains dangerously low.
Critics say the change did not allay their worries: Patients in both treatment arms could potentially not use life-saving therapy and are not properly informed of the risks.
"Vasopressors and fluids are life-saving, and inadequate or excessive amounts of one or the other can cause death," Carome said.
If neither treatment group is close to usual care, as critics argue, investigators may be unable to draw meaningful conclusions – they will not know how the two experimental treatments compare to the usual care. It will also be difficult for security controllers to know if participants are dying at abnormally high rates.
Although patients in the trial are randomly assigned to one of two groups receiving very different treatments, Shapiro insisted that all receive what would be considered "usual care" because the treatment of Sepsis is already variable in the country's hospitals.
In the study, a patient's doctor may deviate from the experimental treatments at any time to provide a life-saving alternative. "If the bedside doctor thinks that the patient needs a specific treatment, he will get it," Shapiro said.
The trial protocol, he noted, was developed by more than 20 experts in emergency medicine and critical care, reviewed by an independent peer review committee and approved by a central committee of institutional review to protect the rights of human subjects.
Medical experts in the field generally agree on the need for better scientific evidence on how to treat sepsis.
"There's not a lot of data on how much liquid to give, how much is enough, how much is too expensive, how much is too little," said Dr. Tiffany Osborn, emergency physician and intensive care specialist. the College of Physicians of Emergency. "This information is difficult to master." Another expert not involved in the trial said the study appeared to challenge current care guidelines.
"Of course, care is often fluids and then vasopressors, and this study is provocative to the extent that it goes against that and says that what we have been doing for decades may not be. to be not good. Said Dr. Matthew Churpek, assistant professor of pulmonary medicine and intensive care at the University of Chicago.
Carome, of Public Citizen, is not convinced that the study provides something like the usual care. "We think CLOVERS can not be repaired," he said.
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