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Insulin Therapy in the ICU:

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1 Insulin Therapy in the ICU:
TRAUMA-ICU NURSING EDUCATIONAL SERIES Insulin Therapy in the ICU: Hyperglycemic Protocols Bradley J. Phillips, M.D. Critical Care Medicine Boston Medical Center Boston University School of Medicine

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): 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 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 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 There were no instances of hemodynamic deterioration or convulsions !
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) Variable Conventional Intensive p Val.
Cr > % % Plasma Urea N2 > % % Dialysis or CVVH 8.2 % % Bilirubin > % % Septicemia % % Tx with Abx > 10 days 17.1% % < 0.001 EMG-Polyneuropathy % % < 0.001 # Transfusions per Pt < 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 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 Blood Sugars in the ICU (in-press)
If Glucose is : Give 2 unit bolus injection and start drip at 1 u/hr. If Glucose is : Give 3 unit bolus injection and start drip at 1 u/hr. If Glucose is : Give 4 unit bolus injection and start drip at 2 u/hr. If Glucose is : Give 6 unit bolus injection and start drip at 2 u/hr. If Glucose is : Give 8 unit bolus injection and start drip at 3 u/hr. If Glucose is : Give 10 unit bolus injection and start drip at 3 u/hr. If Glucose is : Give 12 unit bolus injection and start drip at 4 u/hr. If Glucose is above 401: Give 15 unit bolus injection and start drip at 4 u/hr. Accuchecks q 1 hr. until Glucose is “steady-state” between , then q 2hrs ATC. Adjust Drip Rate as Necessary to fit Target Parameters. Remember, the real goal is , but for practical reasons we accept the range of * 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 Blood Sugars in the ICU (in-press)
A Tight Sliding Scale is also a component of Therapy: Accucheck Treatment 70 or below Give 1/3 amp D50. Recheck in 1 hr. Recheck in 1 hr. No direct treatment units and recheck in 1 hr. units and recheck in 1 hr. units and recheck in 1 hr. units and recheck in 1 hr. units and recheck in 1 hr. units, recheck in 1 hr..? Insulin Drip 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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