Parenterale voeding tijdens kritieke ziekte: bijkomende analyses van de EPaNIC studie
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1 Parenterale voeding tijdens kritieke ziekte: bijkomende analyses van de EPaNIC studie Namens alle auteurs Michaël P. Casaer M.D. Department of Intensive Care Medicine University Hospital Gasthuisberg Catholic University of LEUVEN B-3000 BELGIUM
2 Casaer MP et al. N Engl J Med 2011; 365:
3 ICU patients : unable to feed normally
4 Malnourished patients in ICU patients : bad outcome
5 Early underfeeding and cumulative energy deficit Alberda: Increased mortaltity in BMI <25 or ICM Villet: More infections 2005 Clin. Nutr. Dvir D.: Complications 2006 Clin. Nutr.
6 Improved outcome trough enhanced feeding?
7 Or better feeding when less ill?
8 Does nutrition improve outcome? Adequate number of critically ill patients Randomization Nutrition No Nutrition
9 Does nutrition improve outcome? Power Adequate number of critically ill patients No selection bias Randomization Allocation concealed Nutrition No Nutrition
10 Does nutrition improve outcome? Power Adequate number of critically ill patients No selection bias Randomization Allocation concealed Nutrition No Nutrition Intention to treat Blinded assessors LOS QOL Mortality LOS QOL Mortality
11 Does nutrition improve outcome? Power Adequate number of critically ill patients No selection bias Randomization Allocation concealed Nutrition No Nutrition Intention to treat Blinded assessors LOS QOL Mortality LOS QOL Mortality
12 Nutrition strategies today EN only High risk of underfeeding Associated with Infections Morbidity Death
13 Nutrition strategies today EN only EN + PN High risk of underfeeding Risk of overfeeding and associated metabolic disturbances Associated with Infections Morbidity Death
14
15
16 Conflicting International Guidelines ESPEN Consider PN within 2 days if EN insufficient ASPEN No PN until > day 8, prefer hypocaloric nutrition
17 Causality? RCT! Casaer MP et al. N Engl J Med 2011; 365: EPaNIC multicenter randomized controlled trial (N=4640) clinical trials.gov [NCT ] : Different strategies
18 De EPaNIC intervention
19 EPaNIC intervention : PDMS supported
20 EPaNIC : study population Adult ICU patients, NRS 3, BMI 17 Late PN Early PN N = 2328 N = 2312 Age years 64 ± ± 14 BMI (kg/m²) Median (IQR) 25.6 ( ) 25.8 ( ) NRS score 4 n (%) 1278 (54.9) 1298 (56.1) Sepsis n (%) 505 (21.7) 510 (22.1) Emergency admission n (%) 970 (41.7) 956 (41.3) APACHE II score 23 ± ± 11 Casaer MP et al. N Engl J Med 2011; 365:
21 Nutrition administered Casaer MP et al. N Engl J Med 2011; 365:
22 Nutrition administered Casaer MP et al. N Engl J Med 2011; 365:
23 EPaNIC : In both groups Enteral nutrition initiated on the day after ICU admission Vitamins, trace elements, minerals administered early Overfeeding and hyperglycemia avoided Late PN Early PN Insulin dose 31 (19 48) IU 58 (40 85) IU P < Blood glucose levels 102 ± 14 mg/dl 107 ± 18 mg/dl P < Casaer MP et al. N Engl J Med 2011; 365:
24 EPaNIC : safety outcome Late PN Early PN ICU mortality 6.1 % 6.3 % P = 0.76 Hospital mortality 10.4 % 10.9 % P = day mortality 11.2 % 11.2 % P = 1.00 Casaer MP et al. N Engl J Med 2011; 365:
25 EPaNIC : safety outcome Kaplan-Meier survival Plot 1.0 Early PN Late PN Days after randomization
26 EPaNIC : safety outcome Late PN Early PN ICU mortality 6.1 % 6.3 % P = 0.76 Hospital mortality 10.4 % 10.9 % P = day mortality 11.2 % 11.2 % P = 1.00 Nutrition related complications 18.2 % 18.8% P = 0.62 Hypoglycemia 3.5 % 1.9 % P = Casaer MP et al. N Engl J Med 2011; 365:
27 EPaNIC : primary endpoints Late PN Early PN Discharged alive within 8 days 75.2 % 71.7 % P = ICU stay (days) median (IQR) mean 3 (2 7) 8 4 (2 9) 9 P = 0.02 Time to alive discharge from ICU ( ) P = 0.04 Hazard ratio (95%CI) Adjusted cox proportional hazard analysis Casaer MP et al. N Engl J Med 2011; 365:
28 EPaNIC : primary endpoints Casaer MP et al. N Engl J Med 2011; 365:
29 EPaNIC : infections & inflammation Late PN Early PN Patients with new ICU infection 22.8 % 26.2 % P = Airway or lung 16.4 % 19.3 % P = Bloodstream 6.1 % 7.5 % P = 0.05 Wound 2.7 % 4.2 % P = Highest CRP during ICU stay (mg/ liter) median (IQR) ( ) ( ) P < Casaer MP et al. N Engl J Med 2011; 365:
30 EPaNIC : MOF & recovery from MOF Late PN Early PN Mean duration of CMV 5 days 6 days Tracheostomy 5.8 % 7.0 % P = 0.08 Duration of CVVH IHD median (IQR) mean 7 (3 16) 15 days 10 (5 23) 18 days Proportion of patients During ICU week 1 P = Bilirubine > 3 mg/dl 12.2 % 10.5 % P = During entire ICU stay Gamma GT rise > 79.5 IU/L 32.6 % 38.4 % P = 0.05 Alk. Phosphatase > 405 IU/L 19.9 % 22.6 % P = Hepatic cytolysis (ALT rise > 123 IU/L or AST rise > 114 IU/L) similar in 2 groups Casaer MP et al. N Engl J Med 2011; 365:
31 EPaNIC : hospital stay Late PN Early PN Duration of hospital stay (days) median (IQR) mean 14 (9 27) (9 29) 26 P =0.004 Time to alive hospital discharge ( ) P = 0.04 Hazard ratio (95%CI) (Adjusted cox proportional hazard) Discharge from conventional ward was at discretion of attending physicians, who were blinded for treatment allocation Casaer MP et al. N Engl J Med 2011; 365:
32 EPaNIC : time to (alive) hospital discharge Casaer MP et al. N Engl J Med 2011; 365:
33 EPaNIC : functionality at hospital discharge Casaer MP et al. N Engl J Med 2011; 365:
34 EPaNIC : functionality at hospital discharge Late PN Early PN 6 Minutes Walking Distance (m) 277 ( ) 283 ( ) P = 0.69 N tested Patients independent for all ADL 73.5 % 75.5 % P = 0.31 N tested Casaer MP et al. N Engl J Med 2011; 365:
35 EPaNIC : subgroup analyses Similar effects of late PN in predefined subgroups: Cardiac surgery (N = 2818) BMI 25 OR 40 kg/m² (N = 1989) NRS 5, 6 and 7 (N = 863) Sepsis (N = 1015) Casaer MP et al. N Engl J Med 2011; 365:
36 Subgroup : surgical contra-indication for EN
37 Subgroup : surgical contra-indication for EN Posthoc subgroup, identifiable upon admission
38 Subgroup : surgical contra-indication for EN Late PN Early PN N = 261 N = 256 Enteral intake day 7 (kcal/day) median (IQR) 0 (0 263) 0 (0 142) P = 0.54 Patients with new ICU infection 29.9 % 40.2 % P = 0.01 Discharged alive from ICU 8 days Odds ratio (95%CI) Time to alive discharge from ICU Hazard ratio (95%CI) ( ) + 75% ( ) + 20% Casaer MP et al. N Engl J Med 2011; 365:
39 Subgroup : surgical contra-indication for EN What does this mean? More PN is more toxic? No feeding, irrespective of route, is better?
40 Health economy impact? Late PN Early PN Hospital stay cost mean (IQR) EUR Between patients difference Between groups difference ( ) 1110 EUR EUR ( ) P = 0.04 Cost of PN & hospital stay : flat compensation in Belgian healthcare system Difference explained by antibiotics and laboratory tests Casaer MP et al. N Engl J Med 2011; 365:
41 2 more questions? Is PN only beneficial in the most severely ill patients? Is PN only beneficial at moderate energy doses?
42 Patient specific? The wrong dose for the wrong patient? Perhaps less harmful when more severely ill EPaNIC subgroup analyses NRS 5 Contra indication EN Subgroups by severity of illness
43 Patient specific? The wrong dose for the wrong patient? Perhaps less harmful when more severely ill EPaNIC subgroup analyses NRS 5 Contra indication EN Subgroups by severity of illness
44 Patient specific? The wrong dose for the wrong patient? Perhaps less harmful when more severely ill EPaNIC subgroup analyses NRS 5 Contra indication EN Subgroups by severity of illness
45 EPaNIC, unpublished data M.P.C. & G.V.d.B., K.U.Leuven
46 EPaNIC, unpublished data M.P.C. & G.V.d.B., K.U.Leuven
47 EPaNIC, unpublished data M.P.C. & G.V.d.B., K.U.Leuven
48 EPaNIC, unpublished data M.P.C. & G.V.d.B., K.U.Leuven
49 EPaNIC, unpublished data M.P.C., K.U.Leuven
50 EPaNIC, unpublished data M.P.C. & G.V.d.B., K.U.Leuven
51 Type and severity of illness? No population doing better with early PN was identified. Benefit of Late PN most pronounced in the severely ill. No difference between cardiac surgery and others EPaNIC, unpublished data
52 Mismatch = more or less than the optimal dose
53 RCT s aiming at optimum nutrition intake Adapted from: Singer P ICM
54 Moore RCT s aiming at optimum nutrition intake Dissanaike Dudsk McClave 110% REE Adapted from: Singer P ICM N = 130
55 RCT s aiming at optimum nutrition intake Moore Dissanaike McClave 110% REE Dudsk Prolonged ICU stay Prolonged Mechanical ventilation Increased Infections? Reduced mortality? N = 130
56 Moore RCT s aiming at optimum nutrition intake Dissanaike Dudsk McClave 110% REE N = 4640
57 RCT s aiming at optimum nutrition intake N = 4640
58 RCT s aiming at optimum nutrition intake Cummulative Energy Deficit N = 4640
59 RCT s aiming at optimum nutrition intake Prolonged ICU stay Prolonged Mechanical ventilation Increased Infection N = 4640
60 RCT s aiming at optimum nutrition intake Interpretation of energy intake Based on the 2012 ESPEN presentation by Doig GS Displayed exclusively for the purpose of this discussion with kind permission of dr. Doig N = 1372
61 No effect on primary RCT s aiming at optimum nutrition intake endpoint Shorter mechanical ventilation? Improved subjective wellbeing N = 1372
62 RCT s aiming at optimum nutrition intake Patients expected to stay more than 5 days and live more than 7 days SPN started if EN < 60% of target on day 3 SPN group Control group PN Nutritional Target Day 4 EN ( IC) Day 4 EN Day 1 Day 7 Day 1 Day 7 Heidegger CP. 2012
63 RCT s aiming at optimum nutrition intake Patients expected to stay more than 5 days and live more than 7 days SPN started if EN < 60% of target on day 3 SPN group Control group PN Nutritional Target Day 4 EN ( IC) Day 4 EN Day 1 Day 7 Day 1 Day 7 Less infections Same ICU stay Heidegger CP N = 305
64 A new concept of overfeeding? observational data Hise <80% Preiser <50% Hise ME 2007 J Am Diet Assoc Preiser JC Glucontrol data Poster at ESPEN 2012
65 A new concept of overfeeding? Moore Dissanaike Dudsk Harm Hise <80% Preiser <50% No harm Hise ME 2007 J Am Diet Assoc Preiser JC Glucontrol data Poster at ESPEN 2012
66 Dose-response? Estimating the effect of increasing cumulative energy intake on likelihood of earlier discharge from the ICU AND detecting an eventual superior energy dose EPaNIC, unpublished data
67 Dose-response? Day 1 Day 3 Day 5 Day 7 Late PN patient Early PN patient EPaNIC, unpublished data
68 Dose-response? Day 1 Day 3 Day 5 Day 7 EPaNIC, unpublished data
69 Dose-response? Day 1 Day 3 Day 5 Day 7 EPaNIC, unpublished data
70 Dose-response? Day 1 Day 3 Day 5 Day 7 EPaNIC, unpublished data
71 Dose-response? Day 1 Day 3 Day 5 Day 7 EPaNIC, unpublished data
72 Dose-response? Day 1 Day 3 Day 5 Day 7 EPaNIC, unpublished data
73 Dose-response? Day 1 Day 3 Day 5 Day 7 EPaNIC, unpublished data
74 Dose-response? Likelihood for an earlier 1 discharge from ICU ~ nutrition dose EPaNIC, unpublished data
75 Dose-response? 10% of target /day increase in cumulative energy intake was associated with 2 8% decrease in likelihood for an earlier discharge from ICU ~ p < 0,0001 EPaNIC, unpublished data
76 EPaNIC, unpublished data M.P.C. & G.V.d.B., K.U.Leuven
77 EPaNIC, unpublished data M.P.C. & G.V.d.B., K.U.Leuven
78 EPaNIC, unpublished data M.P.C. & G.V.d.B., K.U.Leuven
79 Is less more when you are really ill? Casaer MP et al. N Engl J Med 2011; 365:
80 Is less more when you are really ill? Casaer MP et al. N Engl J Med 2011; 365: M.P.C.., K.U.Leuven
81 Likelihood of an earlier ICU discharge Relative effect of glucose versus protein intake 1,1 1,05 HR (CI) per 10% of target increase in glucose intake (± 28 g / day) 1 0,95 0,9 HR (CI) per 10% of target increase in protein intake (± 7 g / day) 0,85 day 1 day 3 day 5 day 7 EPaNIC, unpublished data M.P.C. & G.V.d.B., K.U.Leuven
82 Summary of clinical study findings Postponing PN to beyond day 8 (while providing micronutrients) in ICU pts at risk for malnutrition : is superior to preventing caloric deficit with early PN accelerates recovery from organ failure reduces number of infections shortens hospital stay, without compromising functionality at hospital discharge is less costly for patient, hospital and society Casaer MP et al. N Engl J Med 2011; 365:
83 Summary of clinical study findings The untoward effect of Early PN: is independent of type and severity of disease Is present at all nutrition doses except the lowest: less is more even for enteral nutrition The association between enhanced intake and delayed recovery is more pronounced for protein than glucose. Casaer MP et al. N Engl J Med 2011; 365:
84 Why? No indirect calorimetry? No Glutamine? Protein dosing?
85 Underlying mechanisms?
86 Withholding PN while providing parenteral micronutrients +Micronutrients Ziegler T 2011 N Engl J Med
87 Withholding PN while providing parenteral micronutrients =Micronutrients -Micronutrients +Micronutrients Ziegler T 2011 N Engl J Med
88 Withholding PN while providing parenteral micronutrients Ziegler T 2011 N Engl J Med +Micronutrients Less infections Enhanced Recovery
89 Withholding PN while providing parenteral micronutrients Macronutrient restriction + Early Micronutrients Ziegler T 2011 N Engl J Med
90 Withholding PN while providing parenteral micronutrients Macronutrient restriction + Early Micronutrients Derde S 2012 Endocrinology +++
91 Balance between damage induction & removal
92 Under investigation
93 Conclusions Postponing PN to beyond day 7 in ICU patients at risk of malnutrition is superior to preventing caloric deficit with early PN Underlying mechanisms could relate to cellular damage removal, which is suppressed by nutrients
94 Conclusion 3 RCT s, together > 6000 patients: EPaNIC, SPN, Early PN
95 All agree
96 Conclusion 3 RCT s, together > 6000 patients: EPaNIC, SPN, Early PN All Agree Parenteral nutrition before day 8, prevents caloric deficit but Does not improve survival Does not shorten ICU or hospital stay Long term functional outcome results will learn us more
97 A new concept of overfeeding: also true for EN 4000 kcal If less is equally benefical than more, I d prefer less No functional outcome Highly selected patients Rice T 2011 JAMA
98 FUNDING Methusalem (Flemish Government) FWO (Flemish Government) KULeuven GOA UZLeuven KOF Baxter (< 30%) Unconditional research grant and speaker fee
99 Thank You Laboratory and Department of Intensive Care Medicine
100 Thank you
101 Not enough protein in Early PN? Casaer MP et al. N Engl J Med 2011; 365:
102 Not enough protein in Early PN? Casaer MP et al. N Engl J Med 2011; 365:
103 Not enough protein in Early PN? Casaer MP et al. N Engl J Med 2011; 365:
104 Not enough protein in Early PN? Casaer MP et al. N Engl J Med 2011; 365:
105 Balance between damage induction & removal High Energy Hyperglycemia Mortality: 8% GVdB 1 & 2 High Energy TGC mg/dl Mortality: 6%
106 Balance between damage induction & removal High Energy Hyperglycemia Mortality: 8% GVdB 1 & 2 High Energy TGC mg/dl Mortality: 6% LOS ICU 4 [2-9] EPaNIC Low Energy TGC mg/dl Mortality: 6% LOS ICU 3 [2-7]
107 Balance between damage induction & removal High Energy Hyperglycemia Mortality: 8% GVdB 1 & 2 High Energy TGC mg/dl Mortality: 6% LOS ICU 4 [2-9] EPaNIC Low Energy Other Glycemic Target????????? Low Energy TGC mg/dl Mortality: 6% LOS ICU 3 [2-7]
108 How much energy, how much insulin? No Early PN in ICU Early EN? Recent trials showed no benefit Rice TW. CCM 2011 Ibrahim EH. JPEN 2002 Glycemic target based on accuracy of tools and adequacy of insulin provision.
109 ? PN REE?
110 PN REE REE
111 PN REE = PN REE
112 PN REE PN = U
113 Critical illness is a state of excessive availability of glucose and lipids. Wolfe R. Martini W. W. J Surg 2000 PN REE PN = U Inflammation Lipolysis Proteolysis
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