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Tight Glycemic Control An adult perspective

Tight Glycemic Control An adult perspective. Daren K. Heyland Professor of Medicine Queen’s University, Kingston General Hospital Kingston, ON Canada. Case Scenario. Mr PS 76 years old COPD, no DM Severe CAP Day 1- intubated, sedated, high o2 requirements, vasopressor dependent

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Tight Glycemic Control An adult perspective

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  1. Tight Glycemic Control An adult perspective Daren K. Heyland Professor of Medicine Queen’s University, Kingston General Hospital Kingston, ON Canada

  2. Case Scenario • Mr PS • 76 years old • COPD, no DM • Severe CAP • Day 1- intubated, sedated, high o2 requirements, vasopressor dependent • Starting early EN • Glucose 11.1 mmol/L (200 mg/dl)

  3. What would you do? • Start insulin infusion and titrate glucose to 4.4- 6.1 mmol/l • Start insulin infusion and titrate infusion to 7-9 mmol/l • Watchful waiting • Don’t Know • Don’t care

  4. Intensive Insulin Therapy Van den Berge NEJM 2001;345:1359

  5. The Intensive Insulin Therapy Bandwagon What happened? • Endorsed by National and International societies • Recommend by clinical practice guidelines • Standards for hospital accreditation • Part of Institute for Healthcare Improvement and other quality improvement campaign

  6. TIGHT GLYCEMIC CONTROL • Clearly a difference in outcome • High mortality rate in control group? • Repeatability? • Interpretation of findings? • Generalizability of findings? Van den Berge NEJM 2001;345:1359

  7. Feeding • All given IV glucose from day of admission

  8. Nutritional Strategy: Usual Practice?

  9. Canadian RecommendationsEnteral vs. Parenteral Nutrition • Based on one level 1 and 12 level 2 studies, when considering nutrition support for critically ill patients, we strongly recommend the use of Enteral Nutrition over Parenteral Nutrition. www.criticalcarenutrition.com

  10. Canadian RecommendationsCombined EN and PN • Based on 5 level 2 studies, for critically ill patients starting on enteral nutrition we recommend that parenteral nutrition not be started at the same time as enteral nutrition. www.criticalcarenutrition.com

  11. ASPEN/SCCM ICU Nutrition CPGs PN vs Standard Care • In the patient who was previously healthy prior to critical illness with no evidence of protein-calorie malnutrition, use of PN should be reserved and initiated only after the first 7 days of hospitalization (when EN is not available). • If unable to meet energy requirements after 7-10 days by the enteral route, consider initiating PN. • Initiating PN prior to this 7-10 day period does not improve outcome and may be detrimental to the patient. Supplemental PN McClave JPEN 2009;33:277

  12. TIGHT GLYCEMIC CONTROL Harmed by glucose? Rescued by Insulin? Van den Berge NEJM 2001;345:1359

  13. Reproducibility of the Original Protocol? • “If blood glucose is 40-60 mg/dl, stop the insulin infusion, assure adequate baseline glucose intake, and check the blood glucose level within the next hour.” • “If blood glucose approaches the normal range, reduce insulin by 25-50.”

  14. Generalizability of van DeNberghe’s Initial study?

  15. Hypoglycemia rates higher in ITT: 18.7% vs 3.1% • Single center • 1200 MICU patients • Same protocol • Control: 180-215 mg/dl • ITT Group: 80-110 mg/dl • Predominantly PN fed Mortality

  16. Intensive Insulin Therapy and Pentastarch Resuscitation in Severe Sepsis • Hypoglycemia rates higher in ITT: 12.1% vs 2.1% • 18 ICUs in Germany (SepNet) • Control: <180 mg/dl • ITT Group: 80-110 mg/dl • Predominantly enteral fed • 50% surgery • Suspended prematurely because of higher rate of hypoglycemia Mortality Brunkhorst NEJM 2008;358:125

  17. 21 ICUs across Europe • Control: 7.8 -10.0 mmol/L • ITT group: 4.4-6.1 mmol/L • Trials suspended early because of protocol violations • 1,101 patients randomized • 60% surgical/40% medical A prospective multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: The GLUCONTROL study Mortality • Hypoglycemia rates higher in ITT: 8.7% vs 2.7%, p<0.001 Preiser JC Intensive Care Med 2009

  18. NICE – SUGAR Study • Aim • to compare the effects of the two blood glucose targets on 90 day all-cause mortality • Hypothesis • The hypothesis is that there is no difference in the relative risk of death between patients assigned a glucose range of 4.5 - 6.0 mmol/L (81 – 108 mg/dl) and those assigned a glucose range of 10.0 mmol/L or less (180mg/dL or less)

  19. Inclusion Criteria • ICU treatment that extends beyond the calendar day after the day of admission (i.e. on three consecutive days). • Arterial catheter in situ (or imminent) • Consent has been / will be obtained Maximal Generalizability

  20. Severe hypoglycaemia(≤2.2mmol/L: ≤40mg/dL) All reported and investigated as SAEs No long term sequelae reported © The NICE SUGAR Study Investigators 2009

  21. Outcomes: Mortality © The NICE SUGAR Study Investigators 2009

  22. Survival Hazard ratio 1.11 (conventional vs. ITT, p=0.03) © The NICE SUGAR Study Investigators 2009

  23. Pre-defined subgroup pairs © The NICE SUGAR Study Investigators 2009

  24. Conclusions of the Trial • A blood glucose target of 4.5 – 6.0 mmol/L resulted in increased mortality compared to a target of <10.0mmol/L. • In comparison with other trials, severe hypoglycaemia was relatively uncommon but significantly more common in those assigned to intensive glucose control. • On the basis of these results we do not recommend targeting normoglycaemia in critically ill adults.

  25. CMAJ 2009;180:821

  26. Severe Hypoglycemia (SH) in Critically Ill Patients: Risk Factors and Outcomes • Observational study of >5000 ICU patients • 102 had at least 1 episode of glucose < 2.2 mmol (40 mg/dL) • Risk Factors: diabetes, septic shock, renal failure, mechanical ventilation, APACHE score and treatment with ITT. • SH independently associated with increased mortality Employed Case-control matching Krinsley CCM 2007;35:2262

  27. Intensive Insulin Therapy- Rate of Hypoglycemia (<40 mg/dl) - p<0.001 p<0.001 p<0.001 18.7 17.6 14.5 p<0.001 6.8 3.9 4.5 0.5 3.1 30 Conventional Intensive 25 20 % 15 10 p<0.001 5.1 5 0.8 0 Van den Berghe, Van den Berghe VISEP, 2008 NICE-SUGAR, 2009 GluControl, 2006 2001 (ITT), 2006

  28. Kosiborad JAMA 2009:301:1556

  29. Consider Glucose Variability? Ali CCM 2008;36:2316

  30. Intensive Insulin Therapy Benefits Risks Workload

  31. Intensive Insulin Therapy Bandwagon

  32. Canadian RecommendationsIntensive Insulin Therapy We recommend that hyperglycemia (blood sugars > 10 mmol/L) be avoided in all critically ill patients. Based on the NICE-SUGAR study and a recent meta-analysis, we recommend a blood glucose target of around 8.0 mmol/L (or 7-9 mmol/L), rather than a more stringent target range (4.4 to 6.1 mmol/L) or a more liberal target range (10 to 11.1 mmol/L). www.criticalcarenutrition.com Updated May 2009

  33. Avoid Excessive Parenteral Glucose Loading

  34. Tight Glycemic Control Should be ABANDONED! Daren K. Heyland Professor of Medicine Queen’s University, Kingston General Hospital Kingston, ON Canada

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