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Critics demand human sepsis trial be shut down for putting lives at risk

Critics are demanding that a government trial studying treatments for sepsis on humans be shut down.

In a letter to the federal Office for Human Research Protection, consumer advocacy organization Public Citizen wrote that the CLOVERS study is putting participants at risk of serious harm including organ failure and death.

The study is looking at current guidelines to treat sepsis and seeing whether more of IV fluids or of blood-pressure raising medication is beneficial as opposed to the combination that is currently used.

But Public Citizen says using too much of one form of treatment and not the other could be depriving patients of vital care and compared the study to ‘an experiment that would be conducted on laboratory animals’.

Critics are demanding that a government trial studying treatments for sepsis be shut down saying that it is putting patients at risk of organ failure or death (file image)

The CLOVERS, or Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis, study began in March and is expected to be completed in June 2021.

It seeks to enroll in 2,320 patients from 44 US hospitals including Duke University Medical Center, UNC Chapel Hill and Wake Forest Baptist Health.

Funded by the National Institutes of Health, the researchers say they want to better understand one of the leading causes of death in American hospitals.

Sepsis is a life-threatening condition in which chemicals that the immune system releases into the bloodstream to fight an infection cause inflammation throughout the entire body instead.

Many doctors view sepsis in three stages progressing from sepsis to severe sepsis and finally septic shock, a dramatic drop in blood pressure that stops blood flow to the organs and can result in death. 

Symptoms, which can take several days to appear, include fever, lower abdominal pain, chills, pale skin, headache and increased heart rate.

According to the Centers of Disease Control and Prevention (CDC), around 1.7 million Americans develop sepsis every year, killing at least 270,000.

The CDC also says that one in three people who die in a hospital have sepsis. 

Usual care for sepsis sees doctors increasing doses of IV fluids as well as vasopressors, drugs that constrict blood vessels and raise blood pressure.

However, in this trial, half of the patients will receive mostly IV fluids in the ‘liberal fluids’ group and the other half mostly blood pressure-raising medications in the ‘restrictive fluids’ group.

The goal is to see if it’s better to limit fluids and start the patients on the vasopressors or to use more fluids and wait to give patients the drugs. 

‘The guiding principle is patient safety, which takes priority over all else,’ Dr Nathan Shapiro, an associate professor of emergency medicine at Harvard Medical School and co-chairman of the study’s protocol committee, told The New York Times.

Critics of the trial say the participants in the CLOVERS study may be receiving treatment that diverges so much from the typical care that lives are being put at risk.

Even though patients are only enrolled for 24 hours, treating sepsis in its early stages is key.

Those with sepsis but no organ failure have a 15 to 30 percent chance of death while patients who have progressed to severe sepsis or septic shock have a 40 to 60 percent death rate.   

The members of Public Citizen say patients in both groups could potentially go vital hours without receiving proper care. 

For example, in the ‘liberal fluids’ group, patients could go without receiving   vasopressors for hours, even when blood pressure is very low. 

They also argue that participants may not be explained in full the risks of either approach. 

‘The human subjects of the Clovers trial, as designed and currently conducted, are unwitting guinea pigs in a physiology experiment,’ Dr Michael Carome and Dr. Sidney Wolfe wrote in the letter.

‘Both vasopressors and fluids are lifesaving, and inadequate or excessive amounts of either one can cause death,’ Dr Carome told The New York Times.

This comes on the heels of news from the CDC that sepsis is the twelfth leading cause of death.

This is due to a recent resurgence in the US and evidence that suggests sufferers do not immediately seek medical care.

According to a survey conducted this year by the nonprofit organization Sepsis Alliance, only half of adults are aware that sepsis requires urgent medical care.

Daily Mail Online has reached out to Public Citizen for comment.