Children with Sepsis Can Be Treated with Newly Approved Device

A new life-saving therapeutic tool has been approved to treat children with acute kidney injury from sepsis.

Sepsis is a serious condition that causes life-threatening organ dysfunction, but a new treatment promises to help the thousands of children who develop acute kidney injury from sepsis each year.

The device, invented and developed at the University of Michigan, is called the selective cytopheretic device (SCD), or Quelimmune. The Food and Drug Administration (FDA) approved the device last month to treat children with acute kidney injury and sepsis, or a septic condition requiring continuous kidney replacement therapy (dialysis with the artificial kidney) in the intensive care unit.

Sepsis occurs when any kind of infection triggers an extreme response in the body in which toxins are released into the bloodstream and inflammation is triggered, leading to organ shutdown and often death. It can damage the heart, lungs, kidneys, and liver, and mortality rates are high — even with an antibiotic — once it has entered the bloodstream.

White blood cells drive the body’s immune reaction, so the new treatment integrates into the blood during dialysis and selectively calms the excessively activated white blood cells circulating.

Specifically, as an external pump pumps blood through the device, it finds the dysregulated white cells and calms them using a process called pharmacologic manipulation before releasing them back to circulate inside the body.

“Our technology focuses not on treating the bacteria, but treating this dysregulated immunologic system that is overreacting and destroying tissues within the body,” said H. David Humes, M.D., a professor of nephrology and internal medicine and one of the creators of the new treatment, in a news release. “That's the breakthrough with this technology.”

In clinical trials, the device was shown to ameliorate tissue destruction and reverse the course of sepsis, improving the chances of survival. It was also shown to have a favorable safety profile, including no device-related infections or device-related serious adverse events.

Each year, nearly 2 million people and 75,000 children in the United States develop sepsis. That’s more than the number of individuals who suffer from heart attacks or strokes. Sepsis kills roughly 250,000 patients, including 7,000 children, annually — a number greater than the amount of children who die from all pediatric cancers combined.

Researchers are working hard to develop new treatments as a result, and they hope the SCD will reduce the number of deaths caused by sepsis and improve patient outcomes.

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