Nice Sugar Study - Glycemic control in the ICU


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Nice Sugar Study - Glycemic control in the ICU

  1. 1. NICE-SUGAR Intensive versus Conventional Glucose Control in Critically Ill Patients Stephen Wiseman PGY-3 Anesthesiology Resident Cleveland Clinic
  2. 2. Introduction • Hyperglycemia is common in critically ill patients. • In 2001, blood glucose became a major therapeutic target after a study showed a decrease in mortality in SICU patients with strict glucose control. • Current literature shows conflicting results on the effects of more intensive glucose control versus conventional glucose control in critically ill patients.
  3. 3. Van Den Berghe et al: Intensive Insulin Therapy in Critically Ill Patients (2001) • Prospective randomized controlled study. • Enrolled 1548 SICU patients into 2 groups • Intensive therapy targeted glucose between 80-110 and the conventional range was 180-200 • Primary outcome was death in ICU which was 4.6 percent in the Intensive Glucose control group vs. 8.0 percent in Conventional glucose control group which was statistically significant.
  4. 4. Figure 1. Kaplan–Meier Curves Showing Cumulative Survival of Patients Who Received Intensive Insulin Treatment or Conventional Treatment in the Intensive Care Unit (ICU).
  5. 5. Van den Berghe et al 2 Intensive Insulin Therapy in the Medical ICU • Prospective, randomized, controlled study of 1200 patients • Same authors and same conventional and intensive parameters as the first study • Primary outcome was death in hospital which was 37.3% in the intensive group versus 40% in the conventional group which was statistically insignificant.
  6. 6. Wiener et al • Meta analysis of 34 randomized trials totaling 8432 patients. • Hospital mortality did not differ between tight vs. conventional glucose control. • Tight glucose control was not associated with a decreased risk for new dialysis, but was a associated with a decreased risk of septicemia. • Tight glucose control was associated with an increased risk of hypoglycemia.
  7. 7. VISEP • Multi-center, two by two factorial trial. • Patients with severe sepsis were assigned to one of 2 groups either intensive insulin therapy, or conventional insulin therapy. And either starch based colloid or LR for fluid resuscitation. • The trial was stopped early for safety reasons. The use of the more intensive insulin had a higher rate of adverse events and patients were at increased risk of hypoglycemia.
  8. 8. GLUCONTROL • Prospective randomized control trial stopped early due to adverse events in the tight BG control group. • Tight (80-110 mg/dL) vs Conventional(140-180 mg/dL) glucose control. • Incidence of severe hypoglycemia (BG<40 mg/dL) was significantly more frequent in patients assigned to tighter control group. Risk of death was not increased by hypoglycemia. • No difference in mortality 17% vs. 15% and the conclusion of the authors was that there are no apparent benefits of tight glucose control.
  9. 9. NICE-SUGAR Intensive versus Conventional Glucose Control in Critically Ill Patients
  10. 10. Methods • Randomized, prospective un-blinded clinical controlled trial of 6104 patients. • Patients were randomized into one of 2 groups within 24 hours of admission to the ICU if they were expected to be in the ICU for more than 3 days. • The 2 groups were intensive glucose control target (80-108 mg/dL) or the conventional control target (180mg/dL or less).
  11. 11. Figure 1
  12. 12. Methods • Patients were admitted to surgical and medical intensive care units at 42 hospitals internationally. • In the intensive control group, control of blood glucose was achieved with an insulin infusion. • In the conventional group, insulin was administered if the blood glucose level exceeded 180mgdL.
  13. 13. Methods • Patients were followed for 90 days from the time of randomization, or till their death whichever came first. • Death was the primary end-point • Secondary outcomes included survival time within the first 90 days, Cause-specific death, duration of mechanical ventilation and RRT, and stays in the ICU and hospital. • Tertiary outcomes included death within 28 days of randomization, incidence of new organ failure, positive blood culture, RBC transfusion, and volume of transfusion.
  14. 14. Methods • A blood glucose less than 40 mg/dL was considered a serious adverse event.
  15. 15. Results • 3054 patients were assigned to the intensive control group and 3050 to the conventional control group. • 829 patients(27.5%) died in the intensive control group and 751(24.9%) in the conventional- control group which is a difference of 2.6%. • There was no statistical difference between surgical vs. medical ICU patients. • Severe hypoglycemia(<40mg/dL) was recorded in 6.8% of patients in the intensive control group, vs. 0.5% in the conventional group.
  16. 16. Results • No difference between the two groups in median length of ICU or hospital stay. • No difference between number of days of mechanical ventilation, RRT, positive blood cultures, or RBC transfusions.
  17. 17. Discussion Positves: • Large multi-center study • Robust statistical analysis • Use of a uniform insulin protocol between sites. • The primary outcome in this study is unbiased. • Good representation of critically ill patients • This study enrolled more patients than trials that preceded it.
  18. 18. Discussion Limitations: – More patients in the IIT group received corticosteroids which could affect the variable were studying – 10% of the IIT discontinued prematurely. – No significant difference in secondary or tertiary outcomes, despite the difference in the primary outcome, death. – Inclusion criteria, i.e. length of stay is a subjective parameter. 5. The study was not blinded to the treating personnel.
  19. 19. Questions? • 1. What is the optimal target for glucose therapy. • 2. Does a particular sub-set of patients benefit from tight glucose control • 3. What about hypoglycemia? • 4. Strategies for future management of blood glucose in the ICU.
  20. 20. Bibliography • Wiener RS. Wiener DC. Larson RJ. Benefits and risks of tight glucose control in critically ill adults: a meta- analysis.[see comment]. [Journal Article. Meta-Analysis. Research Support, Non-U.S. Gov't. Research Support, U.S. Gov't, Non-P.H.S.] JAMA. 300(8):933-44, 2008 Aug 27. • Preiser JC. Current controversies around tight glucose control in critically ill patients. [Review] [31 refs] [Journal Article. Review] Current Opinion in Clinical Nutrition & Metabolic Care. 10(2):206-9, 2007 Mar.