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NICE-SUGAR: Intensive glucose control in the ICU increased mortality
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Intensive glucose control in critically ill adult patients increased the risk for death by 10%, according to the Normoglycemia in Intensive Care Evaluation — Survival Using Glucose Algorithm Regulation, the NICE-SUGAR trial.
The trial compared intensive vs. conventional glucose control delivered by IV insulin infusion in 6,104 adults admitted to the ICU. Patients were randomly assigned to a treatment arm: 3,054 patients to intensive control (81 mg/dL to 108 mg/dL) and 3,012 patients to conventional glucose control (<180 mg/dL).
The NICE-SUGAR investigators reported that intensive glucose control increased the absolute risk of death at 90 days by 2.6 percentage points, and that the difference in mortality was significant even after adjusting for potential confounders. They said that severe hypoglycemia was “significantly more common” in the intensive control group.
At 90 days, 829 patients assigned to intensive glucose control had died compared with 751 patients assigned to conventional glucose control (OR=1.14; 95% CI, 1.02-1.28).
“Intensively lowering blood glucose to a target of 81 mg/dL to 108 mg/dL does not benefit critically ill patients and may well increase their risk of dying,” Simon Finfer, MBBS, senior staff specialist in intensive care at Royal North Shore Hospital in Sydney, Australia, told Cardiology Today.
Patients intensively treated in the NICE-SUGAR trial were more commonly treated with corticosteroids than those in the conventional treatment arm. The excess deaths in that arm were predominantly from cardiovascular causes.
The two groups did not differ in the median number of days in the ICU or the hospital, and days on mechanical ventilation or renal-replacement therapy.
“Many professional organizations recommend very tight glucose control for ICU patients. They will now need to take this new evidence into consideration and adjust recommendations accordingly,” said Dean R. Chittock, MD, a NICE-SUGAR researcher and head of the division of critical care medicine at the University of British Columbia, Vancouver, in a press release.
Silvio E. Inzucchi, MD, and Mark D. Siegel, MD, in an accompanying editorial, wrote that further exploration of increased mortality with intensive control is warranted in this population, perhaps using a per-protocol analysis.
“Until further evidence becomes available, it would seem reasonable to continue our attempts to optimize the management of blood glucose in our hospitalized patients, especially to avert the extremes of hyperglycemia and hypoglycemia.” – by Katie Kalvaitis
For more information:
- Finfer S. N Engl J Med. 2009;360:1283-1297.
- Inzucchi SE. N Engl J Med. 2009;360:1346.
The hypothesis that complete euglycemia in critically ill patients is beneficial requires that methods be available to assure that such treatment can be accomplished with complete safety. The message of the NICE-SUGAR study, therefore, appears to be the one illustrating lack of safety with current approaches to institution of such treatment protocols, paralleling the findings of the ACCORD study, in which an overly aggressive approach to outpatient glycemic control led to similarly unexpected adverse outcomes. The implication, then, is that the development of new therapeutic approaches will be of great importance in allowing us to adequately assess the hypothesis that glycemic control can lead to improvement in outcomes, whether such studies are undertaken in the acute setting of critical illness or in the chronic setting of treatment of diabetes.
– Zachary T. Bloomgarden, MD
Clinical Professor, Department of Medicine, Mount Sinai School of Medicine