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Insulin Therapy in the ICU:

Insulin Therapy in the ICU:. Hyperglycemic Protocols Bradley J. Phillips, M.D. Burn-Trauma-ICU Adults & Pediatrics. Insulin in the ICU…. Hypergylcemia associated with insulin resistance is common in ICU patients, even those who have not previously had diabetes.

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Insulin Therapy in the ICU:

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  1. Insulin Therapy in the ICU: Hyperglycemic Protocols Bradley J. Phillips, M.D. Burn-Trauma-ICU Adults & Pediatrics

  2. Insulin in the ICU… Hypergylcemia associated with insulin resistance is common in ICU patients, even those who have not previously had diabetes. • Reports of pronounced-hyperglycemia leading to multiple complications • a lack of clinical trials to support • High serum levels of insulin-like growth factor-binding protein 1 increases the risk of death • reflects an impaired response of the hepatocyte to insulin NEJM 2001

  3. Landmark Paper • Van Den Berghe et al. Intensive Insulin Therapy in Critically Ill Patients. NEJM 2001;345 (19): 1359-67. • Prospective, Randomized, Controlled study • 1,548 Adults admitted to a SURGICAL-ICU receiving Mechanical Ventilation • 2 Groups Assigned • Intensive-Insulin: Blood Glucose 80 – 110 • Conventional: Insulin therapy only if Blood Glucose > 215 with a maintenance between 180 – 200

  4. NEJM 2001: Hypothesis Hyperglycemia or relative insulin deficiency (or both) during critical illness may directly or indirectly confer a predisposition to complications, such as severe infections, polyneuropathy, multiple-organ failure, and death.

  5. NEJM 2001: Purpose To determine whether normalization of blood glucose levels with intensive insulin therapy reduces mortality and morbidity among critically ill patients.

  6. Some of the Logistics(1) • Conventional Group • IV Insulin was started if the Blood Glucose exceeded 215 • Infusion was adjusted to maintain level between 180-200 • Intensive-Insulin Group • Started if Blood Glucose exceeded 110 • Infusion was adjusted to maintain level between 80 – 110 • Maximal rate of insulin was set at 50 IU per hr. • Dose adjustment was via strict algorithm followed by ICU-nurses and assisted by a single study-physician that was NOT involved in the clinical mgmt of the patient

  7. Some of the Logistics(2) • On admission, all patients were fed continuously with IV Glucose (200 – 300 g/24 hrs). • The next day, TPN, Combined Enteral-Parenteral, or Total Enteral Feeding was instituted according to a standardized schedule • 20-30 nonprotein kilocalories/kg/24 hrs • AND a balanced formula • 0.13-0.26 g/N2/kg/24 hrs • 20-40 % of nonprotein calories via lipid solution • Total Enteral Feeding was attempted as early as possible

  8. Some of the Logistics(3) • Original Plan was to enroll 2,500 patients in order to detect an absolute difference in mortality of 5% • Interim analysis (conducted every 3 months) of overall mortality required the study be terminated early • Sponsors were not involved in the study design, data collection, analysis, interpretation of the data, or preparation of the manuscript…

  9. Demographics • ½ of the pts were CT Surgery • Note: • the AGE • the Hx of Cancer • Hx of Diabetes • % of pts above 200…

  10. Method – Serious Study • All patients admitted to the SICU from February 2,2000 through January 18, 2001 were considered for enrollment • after consent was obtained • Only 14 pts were excluded • 5 because of participation in other studies • 9 pts were moribund or DNR

  11. A Few Points (1) • 98% of the pts in the Intensive-Insulin Group required therapy • Mean Morning Blood Glucose Level: 103 +/- 19 mg/dl • 39% of the pts in the Conventional Group required therapy • Treated group: Mean Morning Blood Glucose Level: 173 +/- 33 mg/dl • Untreated group: Mean Morning Blood Glucose Level: 140 +/- 25 mg/dl.

  12. Results (1)

  13. Results (2)

  14. Mortality in Perspective (1) • 35 pts in the Intensive Group Died (4.6 %) • 63 pts in the Conventional Group Died (8.0 %) • Apparent Risk Reduction of 42 % • Unbiased Risk Reduction of 32 % • Due to having to adjust for repeated interim analysis • Intensive therapy also reduced the in-hospital mortality – mostly in those pts with multiple-organ failure secondary to a septic focus, regardless if there was a history of diabetes or hyperglycemia. Results were similar in patients who had undergone CT Surgery versus other types of surgery

  15. Results (4)

  16. Mortality in Perspective (2) • Since the introduction of Mechanical Ventilation, few direct interventions have actually improved ICU Survival. Treatment of sepsis with Activated Protein C results in a 20 % relative reduction in mortality at 28 days… glycemic control reduces R.R. of mortality by 42 %.

  17. A Few Points (2) • Hypoglycemia (Blood Glucose < 40 mg/dl) • 39 pts in the Intensive Group • 2 of the 39 pts had associated sweating and agitation • 6 pts in the Conventional Group There were no instances of hemodynamic deterioration or convulsions !

  18. Morbidity (1) Intensive therapy reduced the duration of ICU stay but not overall-hospital stay • Intensive therapy reduced episodes of septicemia by 46 % • Fewer pts in the Intensive Group required prolonged ventilatory support and renal replacement therapy – yet the number of patients that required inotropic or vasopressor support were the same between groups

  19. Morbidity (2) VariableConventionalIntensivep Val. Cr > 2.5 12.3 % 9.0 % 0.04 Plasma Urea N2 > 54 11.2 % 7.7 % 0.02 Dialysis or CVVH 8.2 % 4.8 % 0.007 Bilirubin > 2 26.7 % 22.4 % 0.04 Septicemia 7.8 % 4.2 % 0.003 Tx with Abx > 10 days 17.1% 11.2% < 0.001 EMG-Polyneuropathy 51.9 % 28.7 % < 0.001 # Transfusions per Pt 2 1 < 0.001

  20. Some Critique • European Study (Belgium) • Not Blinded • Team of ICU Nurses and a Specific Study Physician following Pre-designed Protocol • Nutritional Protocol is not described or reported • Insulin Protocol is not described or reported • Independent of Clinical Decision-making Process • SICU-specific patient population • Are the results “too good”… ?

  21. NEJM 2001: Conclusions the use of exogenous insulin to maintain blood glucose at a level less than 110 mg/dl reduces morbidity and morality among critically ill patients in the Surgical ICU, regardless of whether there is a history of diabetes or hyperglycemia.

  22. So, where are we going ? “we need to re-adjust our thinking…” “there is a set-point (similar to a thermostat) that we must adjust clinically in order to apply this information at the bedside…” “no longer can we accept Blood Sugars outside of the normal physiologic range”

  23. Blood Sugars: Insulin Management in the ICU Tisha K Fujii, DO, Bradley J. Phillips, MD • Traditional Thinking: Blood Sugar less than 200 is adequate…after all, the kidney dumps sugar above 180. • 2002 Thinking: The human system is designed to function with a Glucose between 80 and 120. It is a matter of will that we, as healthcare workers, force it to do otherwise. The following is a suggested protocol to allow appropriate “blood sugar control” in the intensive care unit. We have employed its use successfully in a variety of units (i.e. trauma, surgical, medical) and believe that focusing specific attention at undue hyperglycemia is well-worth the effort required. ISPUB.COM

  24. Fujii, Phillips (in-press) • If Glucose is 121 - 150: Give 2 unit bolus injection and start drip at 1 u/hr. • If Glucose is 151 - 175: Give 3 unit bolus injection and start drip at 1 u/hr. • If Glucose is 176 - 200: Give 4 unit bolus injection and start drip at 2 us/hr. • If Glucose is 201 - 250: Give 6 unit bolus injection and start drip at 2 us/hr. • If Glucose is 251 - 300: Give 8 unit bolus injection and start drip at 3 us/hr. • If Glucose is 301 - 350: Give 10 unit bolus injection and start drip at 3 us/hr. • If Glucose is 351 - 400: Give 12 unit bolus injection and start drip at 4 us/hr. • If Glucose is above 401: Give 15 unit bolus injection and start drip at 4 us/hr. • Accuchecks q 1 hr. until Glucose is “steady-state” between 80 - 150, then q 2hrs ATC. Adjust Drip Rate as Necessary to fit Target Parameters. • Remember, the real goal is 80 - 120, but for practical reasons we accept the range of 80 - 150. • * Hourly adjustments are usually in increments of 1-2 units (most patients seem to reach a “steady-state” in the range of 3-5 units/hr.). We have had multiple patients intermittently require rates of 8-12 units per hour.

  25. Fujii, Phillips (in-press) A Tight Sliding Scale is also a component of Therapy: AccucheckTreatment 70 or below Give 1/3 amp D50. Recheck in 1 hr. 71 - 80 Recheck in 1 hr. 81 - 120 No direct treatment 121 - 150 2 units and recheck in 1 hr. 151 - 175 3 units and recheck in 1 hr. 176 - 200 4 units and recheck in 1 hr. 201 - 250 6 units and recheck in 1 hr. 251 - 300 8 units and recheck in 1 hr. 301 - 350 10 units, recheck in 1 hr..? Insulin Drip 351 - 400 12 units, recheck in 1 hr..? Insulin Drip 401 or greater 15 units, recheck in 1 hr., & notify MD. ISPUB.COM

  26. BMC Version: Insulin Protocol Currently in development • Critical Care Medicine • ICU Staff • Pharm. D.’s • Committee and more committees…

  27. WHY ??NEJM 2001: Hypothesis Hyperglycemia or relative insulin deficiency (or both) during critical illness may directly or indirectly confer a predisposition to complications, such as severe infections, polyneuropathy, multiple-organ failure, and death.

  28. Questions & Comments Thank you….

  29. Insulin Therapy in the ICU: Hyperglycemic Protocols Bradley J. Phillips, M.D. Critical Care Medicine Boston Medical Center Boston University School of Medicine

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