INTENSIVE INSULIN THERAPY: A Long History of Conflicting Data.
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1 INTENSIVE INSULIN THERAPY: A Long History of Conflicting Data. Candice Preslaski, PharmD BCPS Clinical Pharmacist Specialist SICU Denver Health Medical Center December 2014
2 OBJECTIVES Review the risk factors and pathophysiology involved in stress hyperglycemia Discuss the theoretical and proven consequences of both hyper- and hypoglycemia Discuss the role and potential benefits of insulin therapy Determine the appropriate blood glucose targets for your ICU patients
3 OBJECTIVES Review the risk factors and pathophysiology involved in stress hyperglycemia Discuss the theoretical and proven consequences of both hyper- and hypoglycemia Discuss the role and potential benefits of insulin therapy Determine the appropriate blood glucose targets for your ICU patients..maybe
4 WHO NEEDS INSULIN? Diabetics Type 1 always! Type 2 if unable to control BG with oral agents DKA or HHS Patients receiving steroids sometimes Some hospitalized patients under stress Infection Trauma Surgery
5 STRESS HYPERGLYCEMIA Defined as a blood glucose > 200 mg/dl Common in critically ill medical, surgical, trauma, and burn patients Generally considered to be an appropriate and adaptive response to insult/injury However, persistent hyperglycemia and insulin resistance have been associated with increased morbidity and mortality Likely the result of a multifactorial process Xiu F, et al. International J of Endocrinology 2014 Farrokhi et al. Best Practice & Research Clinical Endocrinology & Metabolism 2011
6 CAUSES and CONSEQUENCES Farrokhi et al. Best Practice & Research Clinical Endocrinology & Metabolism 2011
7 ASSOCIATED CLINICAL OUTCOMES mortality risk of infections (surgical site, pneumonia, urinary tract) time on mechanical ventilation Polyneuropathy Skeletal muscle wasting Metabolic derangements risk of acute kidney injury need for blood transfusions lengths of stay (hospital and ICU) Ouattara et al. Anesthesia 2005 Williams et al. Neurology 2002 Pittas et al. Arch Int Med 2004 Latham et al. Infect Cont 2001 Van den Berghe et al. NEJM 2001
8 ENDOGENOUS INSULIN Peptide hormone Synthesized and secreted in the pancreas Cleaved in the b cell from pro-insulin to the active insulin peptide and C-peptide Release is stimulated by: Glucose Proteins Vagal stimulation b adrenergic stimulation
9 MECHANISM OF ACTION Primary activity of insulin is regulation of glucose metabolism Lowers blood glucose by: Stimulating peripheral glucose uptake by skeletal muscle fat Inhibiting hepatic glucose production Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis
10 WHAT IS THE GOAL? Intensive Insulin Therapy historically refers to a targeting a blood glucose mg/dl
11 INTENSIVE INSULIN THERAPY Van den Berghe NEJM 2001 Van den Berghe NEJM 2006 NICE-SUGAR NEJM 2009 Population Surgical ICU Medical ICU Mixed ICU N BG Goals Intensive Conventional Intensive Conventional Intensive Conventional <180 Primary Outcome Mortality (I vs C) 4.6% vs 8%, p < 0.04 Mortality (I vs C) 37.3% vs 40%, p=0.33 Mortality (I vs C) 27.5% vs 25%, p=0.02* 10.6% vs 20.2%, p= % vs 38.1%, p=0.05 Secondary Outcomes need for dialysis, septicemia, acute kidney injury, time on ventilator, hypoglycemia, ICU length of stay, polyneuropathy, ICU length of stay time on ventilator blood transfusions
12 INTENSIVE INSULIN THERAPY Van den Berghe NEJM 2001 Van den Berghe NEJM 2006 NICE-SUGAR NEJM 2009 Population Surgical ICU Medical ICU Mixed ICU N BG Goals Intensive Conventional Intensive Conventional Intensive Conventional <180 Primary Outcome Mortality (I vs C) 4.6% vs 8%, p < 0.04 Mortality (I vs C) 37.3% vs 40%, p=0.33 Mortality (I vs C) 27.5% vs 25%, p=0.02* 10.6% vs 20.2%, p= % vs 38.1%, p=0.05 Secondary Outcomes need for dialysis, septicemia, acute kidney injury, time on ventilator, hypoglycemia, ICU length of stay, polyneuropathy, ICU length of stay time on ventilator blood transfusions
13 PRIMARY OUTCOME Mortality benefit seen primarily after 5 days of ICU care
14 SECONDARY OUTCOME VARIABLE (%) CONVENTIONAL (N=783) INTENSIVE (N=765) P VALUE ICU LOS > 14 days 15.7% 12% 0.01 Mechanical ventilation > 14 days 11.9% 7.5% Renal impairment 12.3% 9% 0.04 Dialysis or CVVH 8.2% 4.8% Hyperbilirubinemia 26% 22% 0.04 Bloodstream infection 7.8% 4.2% Antibiotics > 10 days 17.1% 11.2% < Polyneuropathy evidence 51% 28% # blood transfusions/patient 2 1 < 0.001
15 CONTROVERSIES Study population was > 60% cardiac surgery Strict protocol adherence not very practical: Arterial whole-blood samples for measurements every 1 to 4 hours Algorithm was carried out by the study physician (Van den Berghe) not involved in clinical care of the patient IV glucose ( grams/24 hr) was given continuously to all patients on Day 1 then TPN ± enteral feeds were continued thereafter Hypoglycemia (< 40 mg/dl) was observed in 39 patients (5.1%) vs. 6 patients (0.8%), no p-value reported but likely significant NO STUDY HAS BEEN ABLE TO REPRODUCE THE SAME RESULTS..
16 INTENSIVE INSULIN THERAPY Van den Berghe NEJM 2001 Van den Berghe NEJM 2006 NICE-SUGAR NEJM 2009 Population Surgical ICU Medical ICU Mixed ICU N BG Goals Intensive Conventional Intensive Conventional Intensive Conventional <180 Primary Outcome Mortality (I vs C) 4.6% vs 8%, p < 0.04 Mortality (I vs C) 37.3% vs 40%, p=0.33 Mortality (I vs C) 27.5% vs 25%, p=0.02* 10.6% vs 20.2%, p= % vs 38.1%, p=0.05 Secondary Outcomes need for dialysis, septicemia, acute kidney injury, time on ventilator, hypoglycemia, ICU length of stay, polyneuropathy, ICU length of stay time on ventilator blood transfusions
17 OUTCOMES Variable (%) Conventional (n=605) Intensive (n=595) P value Hospital mortality 40% 37.5% 0.33 ICU mortality 26% 24% day mortality 38% 36% 0.53 New kidney injury 8.9% 5.9% Bacteremia 8% 7% 0.5 Weaning from MV HR: 1.21; 95% CI,
18 SUBGROUP: ICU LOS 3 days Variable (%) Conventional (n=605) Intensive (n=595) P value Hospital mortality 52% 43% ICU mortality 38% 31% day mortality 49% 42% 0.06 New kidney injury 12.6% 8% 0.05 Bacteremia 11% 31% 0.09 Weaning from MV HR: 1.43; 95% CI,
19 CONCLUSIONS No mortality benefit in the MICU patient population Only subgroup analysis revealed mortality benefit in those who required ICU care for 3 days Earlier weaning from mechanical ventilation and less acute kidney injury were found in intensive insulin group Limitations: Many subgroup analysis, only post hoc analysis showed significance Larger patient population would be needed to show a mortality reduction with intent-to-treat analysis
20 VISEP Trial Population: 537 patients with severe sepsis Intensive goal mg/dl vs. Conventional mg/dl Primary Outcomes: 28-day mortality Morbidity (sequential organ failure dysfunction, SOFA) Safety end-point: hypoglycemia (BG< 40 mg/dl) Stopped early for safety reasons Patients getting intensive insulin therapy had: no difference in mortality (24.7 vs. 26%) or SOFA score (7.8 vs. 7.7) but increased risk of hypoglycemia (17 vs. 4%) Brunkhorst, et al. NEJM 2008
21 GLUCONTROL Population: 1078 mixed med-surgical ICU patients Intensive goal mg/dl vs. Conventional mg/dl Stopped early due to protocol violations Lack of clinical benefit and increased risk of severe hypoglycemia Severe hypoglycemia (BG<40 mg/dl) more frequent in tight group (8.6 vs. 4%) No difference in mortality (18.7 vs. 15.3%) Preiser, et al. Intensive Care Med 2009
22 INTENSIVE INSULIN THERAPY Van den Berghe NEJM 2001 Van den Berghe NEJM 2006 NICE-SUGAR NEJM 2009 Population Surgical ICU Medical ICU Mixed ICU N BG Goals Intensive Conventional Intensive Conventional Intensive Conventional <180 Primary Outcome Mortality (I vs C) 4.6% vs 8%, p < 0.04 Mortality (I vs C) 37.3% vs 40%, p=0.33 Mortality (I vs C) 27.5% vs 25%, p=0.02* 10.6% vs 20.2%, p= % vs 38.1%, p=0.05 Secondary Outcomes need for dialysis, septicemia, acute kidney injury, time on ventilator, hypoglycemia, ICU length of stay, polyneuropathy, ICU length of stay time on ventilator blood transfusions
23 BASELINE CHARACTERISTICS Characteristic Conventional (n=3050) Intensive (n=3054) Operative admission 37.2% 36.9% Emergent surgery 59.9% 61.3% Trauma 37.9% 41.6% APACHE II score (mean) APACHE II score 25 (%) 31.4% 30.8% Severe sepsis (%) 20.8% 22.4% History of diabetes (%) 19% 20% Mean Admission BG (mg/dl)
24 OUTCOMES
25 90-DAY MORTALITY
26 CONCLUSIONS Conventional glucose control had an absolute reduction in mortality at 90 days of 2.6% vs. intensive insulin control Severe hypoglycemia (<40mg/dL) was significantly reduced in the conventional control group 6.8% to 0.5% Morbidity and complications associated with ICU care were not reduced by intensive glucose control Authors recommend against the use of intensive insulin control in critically ill
27 WHAT IS THE GOAL? Tight Glycemic Control historically refers to a targeting a blood glucose mg/dl Current recommendations lean towards < 180
28 WHAT IS THE GOAL? Tight Glycemic Control historically refers to a targeting a blood glucose mg/dl Current recommendations lean towards < 180 Is there still evidence for tighter control?
29 Scalea et al. TRAUMA PATIENTS Population: 2129 trauma ICU patients Evaluated a patients before and after protocol implementation that targeted goal glucose mg/dl Tight glycemic control significantly: infection rate (29% to 21%) ventilator days (17 to 15) length of stay (24 to 21) mortality (14% to 10%) Scalea et al. Ann Surg 2007
30 TRAUMA PATIENTS Sperry et al. Multicenter implementation of intensive insulin protocol Average maximum daily glucose values from post-injury day #2-5 Stratified outcomes by glucose level: Sperry et al. J Trauma 2009
31 NICE-SUGAR SUBGROUPS
32 NICE-SUGAR SUBGROUPS
33 BURN PATIENTS Hemmila, et al. 152 burn ICU patients Goal mg/dl vs. historical control Patients with a maximum glucose > 140 mg/dl had significantly higher risk of infection (OR 11.3, 95% CI 4-32, p < 0.01) Pneumonia and urinary tract most common infections No difference in mortality Unable to determine if BG control would prevent infection or if BG > 140 was a sign of infection Hemmila, et al. Surgery 2008
34 BURN PATIENTS Murphy, et al. 46 burn ICU patients Goal 150 mg/dl for at least 2 consecutive days by postburn day #3 (n=26) Failure of early glycemic control was associated with higher mortality HR 6.8, 95% CI , p = 0.03 Adjustments for age, TBSA, and inhalational injury Murphy, et al. J Burn Care Res 2011
35 BRAIN INJURY Hyperglycemia strongly associated with increased mortality and worse functional outcome following: Ischemic stroke Intraparenchymal hemorrhage Aneurysmal subarachnoid hemorrhage Traumatic brain injury In patients with ischemic stroke, those who are responsive to insulin therapy have a better prognosis Kruyt, et al. Stroke 2009 Rovlias, et al. Neurosurgery 2000 Fogelholm, et al. J Neurol Neurosurg Psychiatr 2005 Garg, et al. Stroke2006 Capes, et al. Stroke 2001 Gentile, et al. Acad Emerg Med 2006
36 BRAIN INJURY Jacobi, et al. Crit Care Med 2012
37 WHAT IS THE GOAL? Tight Glycemic Control historically refers to a targeting a blood glucose mg/dl Current recommendations lean towards < 180 Is there still evidence for tighter control? Is absolute blood glucose the right target?
38 GLUCOSE VARIABILITY Lanspa, et al. Population: 6101 critically ill adults Electronic protocol for managing insulin Co-efficient of variation independently associated with 30-day mortality OR 1.23 for every 10% increase, p < In non-diabetics: OR 1.37 Lanspa, et al. Critical Care 2014
39 DYSGLYCEMIA and MORTALITY Badawi, et al. Criti Care Med 2012
40 DYSGLYCEMIA and MORTALITY Badawi, et al. Criti Care Med 2012
41 HYPOGLYCEMIA Signs and Symptoms Mild Cold clammy skin Palpitations Tremulous/ weak Sweaty Confused Mood/Personality Change Severe Unresponsiveness Convulsions Coma Death A single incident decreases outcomes in TBI patients Risk factor for cardiovascular events in diabetic patients Can result in agitation, altered mental status, seizures, and death if not corrected
42 NICE-SUGAR HYPOGLYCEMIA
43 WHAT IS THE GOAL? Tight Glycemic Control historically refers to a targeting a blood glucose mg/dl Current recommendations lean towards < 180 Is there still evidence for tighter control? Is absolute blood glucose the right target? DEFINITELY < 180 mg/dl for all critically ill patients
44 WHAT IS THE GOAL? Tight Glycemic Control historically refers to a targeting a blood glucose mg/dl Current recommendations lean towards < 180 Is there still evidence for tighter control? Is absolute blood glucose the right target? PROBABLY < 150 mg/dl for CERTAIN populations especially within surgery
45 WHAT IS THE GOAL? Tight Glycemic Control historically refers to a targeting a blood glucose mg/dl Current recommendations lean towards < 180 Is there still evidence for tighter control? Is absolute blood glucose the right target? NEVER < 110 mg/dl for all critically ill patients
46 WHAT IS THE GOAL? Tight Glycemic Control historically refers to a targeting a blood glucose mg/dl Current recommendations lean towards < 180 Is there still evidence for tighter control? Is absolute blood glucose the right target? AVOID large swings in blood glucose
47 QUESTIONS?
48 SOMETHING TO PONDER. Early mobilization decreased insulin requirements 0.07 units/kg/day vs. 0.2 units/kg/day, p< with similar median blood glucoses vs mg/dl
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