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CONTRÔLE PERIOPERATOIRE DE LA GLYCEMIE Jean-Charles Preiser Philippe Devos Soins Intensifs Généraux Soins Intensifs Généraux C.H.U. Sart Tilman – Liège.

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Presentation on theme: "CONTRÔLE PERIOPERATOIRE DE LA GLYCEMIE Jean-Charles Preiser Philippe Devos Soins Intensifs Généraux Soins Intensifs Généraux C.H.U. Sart Tilman – Liège."— Presentation transcript:

1 CONTRÔLE PERIOPERATOIRE DE LA GLYCEMIE Jean-Charles Preiser Philippe Devos Soins Intensifs Généraux Soins Intensifs Généraux C.H.U. Sart Tilman – Liège SACCharleroi 7 novembre 2006

2 AU PROGRAMME…  INSULINO-RESISTANCE POST- OPERATOIRE  PROGRAMME ERAS  EFFETS CLINIQUES  CONTRÔLE DE LA GLYCEMIE AUX SOINS INTENSIFS

3 LENGTH OF STAY

4 TYPESURGERY

5 BLOODLOSSES TYPESURGERY

6 BLOODLOSSES INSULIN RESISTANCE TYPESURGERY

7 LENGTH OF STAY INSULIN RESISTANCE

8 AU PROGRAMME…  INSULINO-RESISTANCE POST- OPERATOIRE  PROGRAMME ERAS  EFFETS CLINIQUES  CONTRÔLE DE LA GLYCEMIE AUX SOINS INTENSIFS

9 Stress opératoire Allongement durée d’hospitalisation (LOS) Hormones de stress/Cytokines proinflammatoires Résistance à l’insuline

10 RELATIVE INSULIN SENSITIVITY RELATED TO THE TYPE OF SURGERY Thorell A et al, Curr Opin Clin Nutr Metab Care 1999; 2: 69 Percent (%)

11 muscles glucose cerveau acides gras érythrocytes Lymphocytes G.Blancs intestin glutamine foie Tissusagressés lactate Adaptations métaboliques à l’agression Insulino-résistance  alanine adipocytes l glycérol Insulino-résistance  Insulinoindépendance

12 POSTOP vs DIABETES II Carbohydrate Metabolism Postop Type II diabetes Hyperglycemia++ Insulin sensitivity -- Glucose production ++ GLUT4 translocation -- Glycogen formation -- Ljunqgvist Clin Nutr 2001

13 LIVER  gluconeogenesis, from amino acids, lactate and glycerol  glycogenolysis INSULIN-DEPENDENT TISSUES - SKELETAL MUSCLE, MYOCARDIUM - ADIPOSE TISSUE - LIVER  insulin dependent  glucose uptake  glycolysis  glycerol synthesis from trigycerides hydrolysis  lactate and alanine synthesis (not in liver) NON-INSULIN DEPENDENT TISSUES (all other tissues including brain, kidney, immune system, etc. )  glucose uptake  glucose oxidation  plasma glucose KIDNEY  gluconeogenesis  futile cycles alaninelactate glycerol CHO METABOLISM DURING STRESS Biolo et al Intensive Care Med 2002:28:1512

14 TIME COURSE OF INSULIN RESISTANCE Thorell Curr Opin Clin Nutr Metab Care 1999

15 WHO IS RESPONSIBLE?  Hormones (« counter-regulatory »)  Glucagon  Steroïds  GH  Catecholamines  Inflammatory mediators :  TNF, IL1, IL6,…  Insulin (receptor)-mediated feedback mechanisms

16 INSULIN RESISTANCE  Is not beneficial  Should be treated or avoided  Can be decreased by epidural analgesia and preoperative CHO  Allows normoglycemia during feeding  Decreases postoperative morbidity

17 AU PROGRAMME…  INSULINO-RESISTANCE POST- OPERATOIRE  PROGRAMME ERAS  EFFETS CLINIQUES  CONTRÔLE DE LA GLYCEMIE AUX SOINS INTENSIFS

18 ERAS Enhanced Recovery After colorectal Surgery apport oral glucides préop analgésie épidurale mobilisation préopératoire précoce => réduction durée d’hospitalisation (LOS)

19 ERAS Glucides préop solution orale (12.5%) 800 ml la veille à minuit et 400 ml 2-3h avant chirurgie Réduction résistance à l’insuline Amélioration de la balance azotée Réduction de l’anxiété préop Réduction nausée et vomissements postop Amélioration du bien-être postop Réduction durée hospitalisation Hausel J. et al.

20 EFFECTS OF PREOP CHO Nygren Curr Opin Clin Nutr Metab Care 2001

21 PREOPERATIVE CHO  20% glucose IV  12.5 % CARBOHYDRATE DRINK  800 at midnight ml 2-3 hrs prior to surgery (295 mOsm/l)  GASTRIC EMPTYING??

22 EFFECTS OF CHO ON GASTRIC VOLUME AND pH Hausel Anesth Analg 2001 Treatment Gastric volume (ml) - IQR Acidity (pH) IQR Overnight fast (n=89) Placebo (n=86) CHO 12.5 % (n=80)

23 ERAS POSTOPERATIVE INSULIN RESISTANCE Is not beneficial Should be treated or avoided Can be decreased by epidural analgesia and preoperative CHO Allows normoglycemia during feeding Decreases postoperative morbidity Hausel J. et al.

24 INSULIN RESISTANCE  Is not beneficial  Should be treated or avoided  Can be decreased by epidural analgesia and preoperative CHO  Allows normoglycemia during feeding  Decreases postoperative morbidity

25 AU PROGRAMME…  INSULINO-RESISTANCE POST- OPERATOIRE  PROGRAMME ERAS  EFFETS CLINIQUES  CONTRÔLE DE LA GLYCEMIE AUX SOINS INTENSIFS

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27 AU PROGRAMME…  INSULINO-RESISTANCE POST- OPERATOIRE  PROGRAMME ERAS  EFFETS CLINIQUES  CONTRÔLE DE LA GLYCEMIE AUX SOINS INTENSIFS

28 TIGHT GLYCAEMIA CONTROL: The dream comes true Benefits Reduces complication rateReduces complication rate Reduces mortalityReduces mortality Decreases LOSDecreases LOS CheapCheap Easily accessibleEasily accessible Risks /constraints HypoglycemiaHypoglycemia EquipmentEquipment Human resourcesHuman resources

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30 GLUCOSE CONTROL AND MORTALITY IN CRITICALLY ILL PATIENTS Finney JAMA 2003;290:2041  530 patients : cardiothoracic surgery (90%)  Ranges of glycemia :      >2.0  Decreased mortality when glycemia < 1.4 g/l  « Control of glucose levels rather than of absolute levels of exogenous insulin appear to account for the mortality benefit with intensive insulin therapy »

31 CONSTRAINTS AND RISKS OF TIGHT GLUCOSE CONTROL  Constraints  Frequent checks  Cost  Time  Nurses  Exams  Equippment  Glucometers  Automated syringes  Risks  Hypoglycemia  Often asymptomatic (altered mental status)  Neurological symptoms  Adrenergic manifestations

32 THE REAL LIFE (2003) Glycaemia ThresholdIC Units 110 mg/dL3 120 mg/dL5 150 mg/dL mg/dL5 200 mg/dL4 Survey on European ICUs in 2003 GLUCONTROL STUDY - Ph. Devos ESICM 2005

33 ANZICS survey 29 hospitals IssueFrequency IIT protocol for every pt IIT protocol in selected pts 10 % 31% (ICU >3d – sepsis - surgery) At least Once blood glucose > 6.1 mM At least once Blood glucose > 11.1 mM 91.7 % 36.2 % Insulin therapy 31.1% Trigger to start insulin 11.5 mM ( ) Survivors (90%) vs nonsurvivors vs nonsurvivors Max BG 9.5 mM Insulin - 8.3% Max BG 12.0 mM Insulin %

34 D Angus – Ed Abraham AJRCCM 2005 Dec

35 CURRENT MULTI-CENTRE STUDIES ON TIGHT GLUCOSE CONTROL IN ICUS DesignPrimEnd-pt Nb pts required Nb hosp Currentstatus VISEP2x2 Random fluid + BG Mortality60017Stopped Glucontrol Open label Random/ctrlStratified ICU mortality Stopped NICE- Sugar Open label Random/ctrlStratified 90-d mortality Ongoing

36 TIGHT GLYCAEMIA CONTROL: Does the dream come true or time to wake up? Benefits Reduces complication rate ?Reduces complication rate ? Reduces mortality?Reduces mortality? Decreases LOS?Decreases LOS? CheapCheap Easily accessibleEasily accessible Risks - costs HypoglycemiaHypoglycemia EquippmentEquippment Human resourcesHuman resources

37 REASONS FOR DISCONTINUATION  VISEP (March 2005 – 488 patients)  Unacceptably high rate of hypoglycemia  No beneficial effect on outcome

38 VISEP STUDY 488 patients in 17 centres

39 GLUCONTROL A Multi-Centre Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

40 SAMPLE SIZE  Expected outcome (considering a baseline ICU mortality of 20%)  4% decrease of absolute ICU mortality (20% relative)  Power 80%  1447 patients /group (total 2894) required (initial estimate)

41 GLUCONTROL  Prospective, randomised, controlled, investigator-blinded and multicentric study  Aimed at comparing the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level  between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) = GROUP A  and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively) = GROUP B

42 GLUCONTROL  Primary Outcome : absolute intensive care unit (ICU) mortality (target = 4%-decrease).  Secondary outcome variables :  in-hospital and 28-day mortality,  lengths of stays in ICU and in the hospital,  length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycaemia,  rates of infections and organ failures,  number of red-cells transfusions.

43  Inclusion criteria  18 years or older  admitted in an ICU  Exclusion criterion  Absence of signed informed consent GLUCONTROL

44 GLUCONTROL  Planning :  Interim analysis each 100 ICU deaths  In order to detect a 4% decrease of absolute mortality 3500 patients to be included

45 GLUCONTROL  7 countries  Austria, Belgium, France, Israel, The Netherlands, Slovenia and Spain.  21 units in 19 centres

46 GLUCONTROL  Planning :  Interim analysis each 100 ICU deaths  In order to detect a 4% decrease of absolute mortality 3500 patients to be included  STUDY STOPPED ON MAY 29th, 2006  Safety concern  High rate of unintended protocol violations

47 1108 recruited patients 1108 recruited patients 1099 randomized patients 1099 randomized patients Patients available for the analysis: Patients available for the analysis: n = 1091  Group A: 538 patients  Group B: 553 patients Length of observation: Length of observation:  from 1 to 56 days (median: 5; IQR: 3 – 10) GLUCONTROL

48 Unit Number of patients 1091 patientsGLUCONTROL

49 (3.0 – 10.5) 5.0 (3.0 – 10.0) ICU LOS, day % 3.5 % Readmission % 32.8 % 18.4 % 8.1 % 41.6 % 31.8 % 18.6 % 8.0 % Category Medical Medical Scheduled Surgery Scheduled Surgery Emergency Surgery Emergency Surgery Trauma Trauma /208336/199 Sex ratio, M/F (51 – 74) 65 (51-74) Age, yr P Group B (n = 553) Group A (n = 538) Median (IQR) GLUCONTROL

50 Age, yr Group A Frequency Age, yr Group B FrequencyGLUCONTROL

51 Group A (n = 538) Group B (n = 553) P SubCategory Trauma Trauma Neurological Neurological Gastroenterological Gastroenterological Orthopaedic Orthopaedic Renal Renal Cardiac Cardiac Respiratory Respiratory Vascular Vascular Hematological Hematological Other Other 5.9 % 15.1 % 18.1 % 1.2 % 2.2 % 34.0 % 18.9 % 1.6 % 0.4 % 2.8 % 6.1 % 13.3 % 14.7 % 0.6 % 2.7 % 34.5 % 18.9 % 3.4 % 0.8 % 5.1 % GLUCONTROL

52 Group A (n = 538) Group B (n = 553) P APACHE II score 20 ( ) 20 (15 – 26) SOFA score 7 (5 – 9) Preexisting Diabetes: Type of diabetes: Insulin- dependent Insulin- dependent Non insulin-dependent Non insulin-dependentHbA1c: > 6.5 % > 6.5 % 16.4 % 34.4 % 65.6 % 16.3 % 23.7 % 28.0 % 72.0 % 25.1 % GCS 15 (8 -15) 15 (9 – 15) Median (IQR) GLUCONTROL

53 Group AGroup B p < GLUCONTROL 118 ( ) 144 ( ) Number of glycemia/patients: From 2 to 856 measures (median: 33; IQR: ) Blood glucose, mg/dl

54 Treatment, days Group A Group B Median with IQR * * * * * * * * * * * * * * * * p < 0.001GLUCONTROL Blood glucose, mg/dl

55 Treatment, days Group A Group B Median with IQR * * * * * * * * * * * * * * * * p < 0.001GLUCONTROL Blood glucose, mg/dl

56 Treatment, days Blood glucose, mg/dl Group A Group B Median with IQR * * * * * * * * * * * * * * * * p < 0.001GLUCONTROL

57 Variability of blood glucose Group AGroup B SD of blood glucose, mg/dl p NSGLUCONTROL

58 Blood glucose (integrated), mg/dl Blood glucose (arithmetic mean), mg/dl Y = X r² = 0.928GLUCONTROL

59 < (0 – 5) 0 (0 – 1) Insulin free days, days < (0.0 – 1.4) 1.8 (1.0 – 2.9) Insulin rate, U/hr < Patients treated by insulin IV (ITT), % < Patients treated by insulin IV (PP), % P Group B (n = 553) Group A (n = 538) Median (IQR)GLUCONTROL

60 Group A INSULIN FREE DAYS, days Group B p < GLUCONTROL Median with IQR

61 Median (IQR)GLUCONTROL < % 9.8 % Patients with hypoglycemia < 40, % P Group B (n = 553) Group A (n = 538)

62 Multivariable analysis: hypoglycemia < 60 mg/dl Adjusted OR 95 % CI p Group A Death Apache II – – Multivariable analysis: hypoglycemia < 40 mg/dl Adjusted OR 95 % CI p Group A Death Apache II – – – GLUCONTROL

63 (3-11) 5 (3-10) ICU LOS, days Mortality rate, % P Group B (n = 553) Group A (n = 538) Median (IQR)GLUCONTROL

64 Mortality rate, % P Group B (n = 553) Group A (n = 538) Median (IQR)GLUCONTROL

65 Number of inclusions Cumulative Death rate, % Group AGroup BGLUCONTROL

66 % 18.3 % Death among patients with Hypoglycemia < 40, % Mortality rate, % P Group B (n = 553) Group A (n = 538) Median (IQR)GLUCONTROL

67 Univariable analysis Crude OR 95 % CI p Group A Multivariable analysis Adjusted OR 95 % CI p Group A Gender (male) Age, yr Apache II SOFA – – – – GLUCONTROL RISK OF DEATH

68 Non diabetic patients: 855 Non diabetic patients: 855 Diabetic patients: 236 Diabetic patients: 236  Type I : 64  Type II: 144  Unsuspected (HbA1c > 6.5 %): 28 GLUCONTROL

69 Group A (n = 538) Group B (n = 553) P Previous Diabetes: Type of diabetes: Insulinodependent Insulinodependent Non Insulinodependent Non Insulinodependent Unsuspected prior Unsuspected prior admission admission with HbA1c > 6.5 % with HbA1c > 6.5 %HbA1c: > 6.5 % > 6.5 % 19.0 % 5.8 % 11.0 % 2.2 % 16.3 % 24.2 % 6.0 % 15.4 % 2.9 % 25.1 % GLUCONTROL

70 Group A Group B P Non diabetic patients 855 patients: 855 patients: Deaths Deaths Diabetic patients 236 patients 236 patients Deaths Deaths % % % % GLUCONTROL

71 TIGHT GLYCAEMIA CONTROL: Risks Benefits

72 TIGHT GLUCOSE CONTROL WITH INTENSIVE INSULIN THERAPY Hazards of hyperglycemia Risks of hypoglycemia Being funambulist may not be accessible to everyone


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