NICE-SUGAR
Trial question
What is the role of intensive glucose control in critically ill patients?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 6030
6030 patients (2207 female, 3823 male).
Inclusion criteria: adult medical and surgical patients admitted to the ICU who were expected to require treatment in the ICU on ≥ 3 consecutive days.
Key exclusion criteria: age < 18 years, imminent death (cardiac standstill or brain death anticipated within 24 hours), ICU admission for treatment of diabetic ketoacidosis or hyperosmolar state, previous hypoglycemia without full neurological recovery, or at high risk of hypoglycemia.
Interventions
N=3016 intensive glucose control (with a target blood glucose range of 81-108 mg/dL).
N=3014 conventional glucose control (with a target of ≤ 180 mg/dL).
Primary outcome
All-cause mortality at day 90
27.5%
24.9%
27.5 %
20.6 %
13.8 %
6.9 %
0.0 %
Intensive glucose
control
Conventional glucose
control
Significant
increase ▲
NNH = 38
Significant increase in all-cause mortality at day 90 (27.5% vs. 24.9%; OR 1.14, 95% CI 1.02 to 1.28).
Secondary outcomes
No significant difference in mechanical ventilation (96% vs. 95.3%; AD 0.7%, 95% CI -0.3 to 1.76).
No significant difference in RRT (15.4% vs. 14.5%; AD 0.9%, 95% CI -9 to 2.7).
No significant difference in death at day 28 (22.3% vs. 20.8%; OR 1.09, 95% CI 0.96 to 1.23).
Safety outcomes
Significant difference in severe hypoglycemia (6.8% vs. 0.5%).
Conclusion
In adult medical and surgical patients admitted to the ICU who were expected to require treatment in the ICU on ≥ 3 consecutive days, intensive glucose control was inferior to conventional glucose control with respect to all-cause mortality at day 90.
Reference
NICE-SUGAR Study Investigators, Finfer S, Chittock DR et al. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97.
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