ORLANDO -- The risks of tight glycemic control for patients in intensive care outweigh the benefits, a Belgian researcher said here.
ORLANDO, Feb. 20 -- The risks of tight glycemic control for patients in intensive care outweigh the benefits, a Belgian researcher said here.
That's the clinical message from the aborted European Glucontrol Trial, which was halted prematurely last May when a monitoring committee found an excess of deaths associated with the low-glucose group in the study, according to Jean-Charles Preiser, M.D., Ph.D., of the University Hospital Center in Lige.
The safety signal was premature, however, and when more data were included, overall, patients kept under tight glycemic control were not at greater risk of death than those on a looser regimen, Dr. Preiser told a latebreaker session at the Critical Care Congress of the Society for Critical Care Medicine.
But equally, he said, there was no mortality benefit for the 536 patients randomized to a target of 80 to 110 milligrams per deciliter of glucose over the 546 patients whose blood glucose target was between 140 and 180 mg/dL.
On the other hand, he said, patients in the low glucose group had significantly more incidents of hypoglycemia (at P<0.001). Indeed, if the definition of hypoglycemia was set at 60 mg/dL, being in the low glucose group led to seven-fold greater risk of the condition, compared to those in the other group.
"There is no reason to recommend the use of 110 milligrams as a target for insulin therapy," Dr. Preiser said. In fact, aiming for the higher level of 140 or 150 would be "wise," he said.
The insulin regimens used were broadly successful in achieving the study goals:
Mortality in the ICU, during the hospital stay, and at 28 days was not significantly different between the groups. There was no difference in length of stay on the ICU.
Patients in the low glucose group had significantly fewer insulin-free days (at P<0.0001) than those in the other group.
The multi-center international study was intended to extend and verify two single-center Belgian studies published in 2001 and 2006 that showed about a 6% mortality benefit for surgical ICU patients kept under tight glycemic control.
Those studies were widely accepted despite their relatively small size and homogenous northern European patient population, commented Clifford Deutschman, M.D., of the University of Pennsylvania Medical School in Philadelphia, who moderated the latebreaker session.
Whether the results apply in a broader situation was unclear, but Dr. Preiser's data calls the issue into doubt, he said, and intensive care physicians need to "think hard and long" about aiming for tight glycemic control.
Also, he said, "we need to be very conservative about starting insulin regimens the minute someone comes into the ICU."