Study Says Popular ICU Glucose Treatment Could be DangerousAug 27, 2008 | Parker Waichman LLP
Sepsis Treatment Called Tight Glucose Control.
A new analysis by the Dartmouth Medical School questions the benefits of a widely accepted sepsis treatment called tight glucose control. This treatment is used for patients not only with sepsis, but also with other critical illnesses. The Dartmouth researchers are concerned the treatment not only might not help such patients, it could cause harm.
Tight glucose control involves nurses testing patients' blood-sugar levels hourly, and, if required, adjusting intravenous insulin drips. The treatment began being heavily promoted by medical groups such as the Surviving Sepsis Campaign back in 2004. That promotion was prompted on one study, which took place in Belgium that indicated that critical-care patients often had high blood sugar that could lead to fatal complications.
Sepsis is a bloodstream infection that can result in death by causing multiple organ failure. The Surviving Sepsis Campaign is a larger group that includes the American Thoracic Society, the Society of Critical Care Medicine, and the American College of Emergency Physicians. At its urging, and following the single 2001 Belgium study of 1,548 patients, hospitals adopted the glucose-control treatment. That single study concluded that tight glucose control treatment reduced the death rate in the hospital's surgical intensive-care unit to 4.6% of total critical-care patients from 8.0%.
The Dartmouth researchers found that the glucose-control treatment failed to save more lives than standard sepsis therapy, such as antibiotics, fluids, and blood-pressure medicines. The researchers also found that the treatment significantly increased the incidence of hypoglycemia—low blood sugar—which, in extreme cases, can lead to coma and seizures that can trigger devastating brain damage. "In critically ill adult patients, tight glucose control is not associated with significantly reduced hospital mortality but is associated with an increased risk of hypoglycemia," Dartmouth researchers reported in Wednesday's Journal of the American Medical Association. "Overall, it seems that the time has come to reconsider whether professional societies should continue to recommend tight glucose control as the standard of care in all critically ill adults," said Renda Soylemez Wiener, a critical-care doctor and lead author of the study.
Glucose-Control Therapy Had No Significant Effect On Death Rates.
The research revealed that glucose-control therapy had no significant effect on death rates; that hypoglycemia was multiplied five-fold among patients on the therapy; and that glucose-control treatment was linked to a modest reduction in sepsis infection. The researchers also pointed out that, "Hypoglycemia is not benign in critically ill patients. "It has been linked to serious neurologic events ranging from seizures to coma."
In January, the New England Journal of Medicine published a German study of 537 patients from multiple hospitals in which severe sepsis patients were randomly assigned to intensive insulin therapy such as tight glucose control, or to standard treatment. The trial was stopped early for safety reasons, including a four-fold increase in hypoglycemia and a doubling of serious adverse events. Those researchers concluded that intensive insulin therapy "placed critically ill patients with sepsis at increased risk for serious adverse events related to hypoglycemia.”
Need Legal Help Regarding ICU Glucose Therapy Side Effects.