Sepsis trial slated for putting lives at risk

Critics from the consumer advocacy organisation Public Citizen are insisting that a US government trial investigating treatment for sepsis be closed down, claiming that the study is exposing participants to the risk of serious harm, including organ failure and death.

The study is researching sepsis treatment guidelines and investigating whether more blood pressure raising medication or IV fluids is more beneficial than the combination currently used. Public Citizen says changing the combination to too much of one treatment and not the other could deprive patients of vital care, comparing the study to ‘an experiment that would be conducted on laboratory animals’.

The study, known as CLOVERS (Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis) began earlier this year and is expected to be completed by mid-2021. It will involve over 2,000 patients from 44 US hospitals and will be funded by the National Institutes of Health.

Dr Nathan Shapiro, co-chairman of the study’s protocol committee and association professor of emergency medicine at Harvard Medical School, said “The guiding principle is patient safety, which takes priority over all else.”

Critics of the study say the participants could be receiving treatment that diverges to such an extent from the current care that their lives are being put at risk.

A representative from Public Citizen said “The human subjects of the CLOVERS trial, as designed and currently conducted, are unwitting guinea pigs in a physiology experiment.

“Both vasopressors and fluids are lifesaving, and inadequate or excessive amounts of either one can cause death.”

This comes on the heels of recent news from health protection agency CDC that sepsis is currently the twelfth leading cause of death.

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Posted by Karen Motley, Paralegal, Clinical Negligence Department, Chadwick Lawrence LLP (karenmotley@chadlaw.co.uk), medical negligence lawyers and clinical negligence solicitors in Huddersfield, Leeds, Wakefield and Halifax, West Yorkshire.

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