NICE-SUGAR Study – Can we finally put this issue to rest?
This week’s issue of NEJM features another in a long debated series of trials that investigates the benefits of “tight” vs “conventional” glycemic control in the ICU. Is this the one that finally gives us the answer? Let’s find out…
The NICE-SUGAR Study Investigators are a multinational, multicenter and multidisciplinary collaboration. The primary objective of this trial was to find the optimal glycemic level for critically ill patients. Patients expected to stay in the ICU for >3 days were enrolled within 24 hours of admission to the ICU. They were randomized to either recive INTENSIVE (81-108 mg/dl) or CONVENTIONAL (<180 mg/dl) therapy. The primary endpoint was 90 day mortality (any cause / after randomization).
After enrolling 6104 patients, 3054 received intensive rx and 3050 received conventional rx. Groups were relatively well matched at baseline. The major difference in primary outcome was a RRR of ~ 9% in the conventional group (24.5% vs 27.5%). This corresponded to an odds ratio of 1.14 (95% CI 1.02-1.28), p=0.02. There was no differernce in the treatment effect when looking at medical vs. surgical patients. Of note, severe hypoglycemia (<40) occured ~13x more often in the intensive group (0.5% vs 6.8% p<0.001). No other significant differences upon subgroup analysis or secondary outcomes were found.