Transcript McClave - Palmetto Health
Nutrition as Therapy: Strategies for the Delivery of Enteral Nutrition
Stephen A. McClave, MD Professor of Medicine University of Louisville School of Medicine Louisville, Kentucky USA
Disclosures
As it pertains to this CME activity, I have the following disclosures to report:
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Grant/Research Support-Covidien, Nestle
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Consultant-Nestle, Abbott, Covidien
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Speaker’s Bureau-Nestle, Abbott Stephen A. McClave, MD
What
’
s Driving Nutrition Therapy?
Nutrition Rx This Way Caloric deficit; Timing of EN initiation; Who benefits from EN Rx?
Effect of Caloric Deficit
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10,000 kcal Bartlett (1982) 1 Mortality increases 27% →76% Mault (2000) 2 Durat MV increases ICU LOS increases 10 → 20 days 16 → 25 days Ramp-Up
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5,000 kcal Villet (2005) 3 * p<0.05
Hosp LOS (p=0.0001) Complics (p=0.0003) Infections (p=0.004) Durat MV (p=0.0002) Caloric Deficit
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4,000 kcal Dvir, Singer (2006) 4 ARDS (p=0.0003) Renal failure (p=0.0001) Sepsis (p=0.003) Need for surgery (p=0.0001) Total complications (0.0001) 1 Surg 1982;92:771 2 JPEN 2000;24:S4 3 CCM 2005 4 Clin Nutrit 2006;25:37
Effect of Early Initiation of Nutrition Therapy
• •
Meta-Analysis of 6 PRCTs (n=234) Early (within 24 hrs) vs Later Rx (1- 4 days after admission) Results: Mortality (OR = 0.34, 95%CI 0.14-0.85) Pneumonia (OR = 0.31, 95%CI 0.12-0.78) Mortality Int Care Med 2009;35:2018
Who Benefits from Enteral Nutrition?
• •
Jie B et al Nutrition 2012 Prospective Multicenter cohort study n=1085 Pre-op Nutrition therapy NRS-2002 (n=512 at risk) 102 with NRS ≥ 5 Results When NRS ≥ 5 complications 50.6 vs 25.6 % When NRS ≥ 5 length of stay 17 to 13 days No benefit in NRS < 5 Jie B et al Nutrition 2012 Miller KR et al JPEN 2011
Who Benefits from Enteral Nutrition?
Rx Effect on High Risk Pts p=0.01
Heyland DK (Crit Care 2011;6:1)
Value of EN in the ICU
• • •
Rationale: Prevents gut permeability and cytokine storm Stimulates anti-inflammatory Th-2 CD 4 Helper lymphocyte cell line Promotes role of commensal bacteria, anti-inflammatory microbiota Takes advantage of anti-inflammatory effects of oral tolerance Delivers SCFAs to cecum, anti-inflam effect of butyrate receptors Delivers LCFAs to duodenum causing vagal anti-inflam effect Evidence: Early vs delayed feeding PRCTs Early EN vs Standard Rx PRCTs Concern: Underfeeding, difficulties in EN delivery
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Providing EN in ICU is Difficult
“
Physician-directed Malnutrition
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QA Monitor over 3 mos (n= 1192) 1 21.9% were NPO > 3 days Durat NPO mean 5.2d (range 0-16) EN is hard work!
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Anticipate under-delivery of EN Study Ibrahim 2 McClave 3 Arabi 4 Required 100% 100% 100% Intended 100% 65% 90-100% Actual 27.9% 50% 71.4%
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University of Louisville experience (% goal delivered) CCU/Neuro ICU 50% SICU 20% MICU Burn ICU 80% 100% 1 JPEN 2011;35(3):337 2 JPEN 2002;26:174 3 Crit Care Med 1999;27:1252-6 4 AJCN 2011;93:569
Value of PN in the ICU
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Rationale Value of protein in critical illness Neg outcome with loss of LBM Increased protein turnover (mobilization, acute phase, wound healing, gluconeogenesis, renal acid/base balance) Conditionally essential AAs (glutamine, tryptophan, phenylalanine, tyrosine) Consistent adequacy of nutrition Rx and approp glucose control
• •
Evidence - Conflicting Concern Few mechanisms of immune modulation PN benefit should be more likely in high risk patients Ineffective, may worsen outcome in moderate risk patients Lawson CM (Curr Gastro Rep 2011) Bistrian BR (CCM 2011;391533)
EPaNIC Trial
What is Best Way to Reduce Caloric Deficit?
Europe Van den Berghe USA Casaer MP, Van den Berghe G (NEJM 2011;365:506)
SCCM/ASPEN (USA) vs ESPEN (Europe) versus
Results of EPaNIC Study
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PRCT 4640 adult ICU pts multicenter Received 2009 Stoutenbeek Award for study design All pts started on EN, tight glucose control
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Results Infection ICU LOS Hosp LOS Durat CRRT MV > 2 days Hosp mortality ICU dschg alive Healthcare cost Early PN ( ESPEN ) Late PN ( ASPEN ) (n=2312) (n=2328) 26.2% 22.8% * 4.0 d 14.0 d 10.0 d 40.2% 10.9% 71.7% 17,973 E 3.0 d * 12.0 d * 7.0 d * 36.3% * 10.4% 75.2%* (p=NS) 16,863 E * * p<0.05 MP Casear, G Van Den Berghe (NEJM 2011;365:506 )
Swiss Study Supplemental PN
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PRCT in high risk Med ICU patients (n=275) Functional gut, expected ICU LOS>5d Study pts: Add PN after 3 days if <60% Measured REE Controls: EN alone
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Results (EN vs SPN) Coefficient Signif New infection -0.27
Mech vent hrs -87.4
Hosp LOS -2.70d
0.019
0.001
0.009
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Key issues : Wait longer to add PN (at 72 hrs) Only add if EN feeds <60% goal M Berger, C Pichard (24 th ESICM Congress, Berlin, Germany, October 1-5, 2011)
Issue of Supplemental PN
Re-Analysis of EPaNIC Study in Patients With Greatest Dz Severity What have we learned?
APACHE II vs Mort, LOS, MOF < 10 10-20 20-30 >30 Favors Early PN Favors Late PN
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Tremendous adverse effect from PN use outside the setting of intestinal failure Greet Van den Berghe (DDW 2012 Presentation)
• • •
When Do We Feed?
Recognize true contraindications to EN Don
’
t misinterpret mild-moderate degree of intolerance, dysfunction Consider judicious use of PN if EN insufficient
• •
Take advantage of opportunity to deliver early EN Have skill set, expertise, protocols, strategies in place to activate
Today
’
s Total Volume
Reduce Deficit with EN:
#1
Volume-Based Feeding
Volume-Based Feeding Rate-Based Feeding
Chart to Calculate Adjusted Rate
Volume-Based Protocol Rate for hours remaining Gastric Enteral Feeding Guidelines to Provide Goal Rate Ordered
50 45 40 35 30 25 20 15
Goal Goal Total mL/hr ml formula / 24hrs per 24 hrs
100 2400 95 90 85 2280 2160 2040 80 75 70 65 60 55 1920 1800 1680 1560 1440 1320 1200 1080 960 840 720 600 480 360
24
100 95 90 85 80 75 70 65 60 55 50 45 40 35 30 25 20 15
Color Key:
21 16 52 47 42 37 31 26
23
104 99 94 89 83 78 73 68 63 57
22
109 104 98 93 87 82 76 71 65 60 55 49 44 38 33 27 22 16
Hours Remaining in Day to Refeed Withheld Enteral Formula (Due to Feeding on Hold for Test or Procedure) 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4
114 109 103 97 91 86 80 74 69 63 57 51 46 40 34 29 23 17 120 114 108 102 96 90 84 78 72 66 60 54 48 42 36 30 24 18 126 120 114 107 101 95 88 82 76 69 63 57 51 44 38 32 25 19 133 127 120 113 107 100 93 87 80 73 67 60 53 47 40 33 27 20 141 134 127 120 113 106 99 92 85 78 71 64 56 49 42 35 150 143 135 128 120 113 105 98 90 83 75 68 60 53 45 38 160 152 144 136 128 120 112 104 96 88 80 72 64 56 48 40 171 163 154 146 137 129 120 111 103 94 86 77 69 60 51 43 185 175 166 157 148 138 129 120 111 102 92 83 74 65 55 46 28 21 30 23 32 24 34 26
White=Tolerated by G Tube
37 28 200 190 180 170 160 150 140 130 120 110 100 90 80 70 60 50 40 30 218 207 196 185 175 164 153 142 131 120 109 98 87 76 65 55 44 33 240 228 216 204 192 180 168 156 144 132 267 253 240 227 213 200 187 173 160 147 280 280 270 255 240 225 210 195 180 165 280 280 280 280 274 257 240 223 206 189 280 280 280 280 280 280 280 260 240 220 280 280 280 280 280 280 280 280 280 280 280 280 280 280 280 280 280 280 280 280
3
280 280 280 280 280 280 280 280 280 280 120 108 96 84 72 60 133 120 107 93 80 67 150 135 120 105 90 75 171 154 137 120 103 86 200 180 160 140 120 100 240 216 192 168 144 120 280 270 240 210 180 150 280 280 280 280 240 200 280 280 280 280 280 280 48 36 53 40 60 45 69 51 80 60 96 72 120 90 160 120 240 180
Green=Arbitrary Maximum Rate Tolerated by G Tube 2
280 280 280 280 280 280 280 280 280 280 280 280 280 280 280 280 280 280
1
280 280 280 280 280 280 280 280 280 280
Goal Goal Total mL/hr ml formula / 24hrs per 24 hrs
100 2400 95 90 85 2280 2160 2040 80 75 70 65 60 55 50 45 40 35 30 25 20 15 1920 1800 1680 1560 1440 1320 1200 1080 960 840 720 600 480 360
Small Bowel Enteral Feeding Guidelines to Provide Goal Rate Ordered Arbitrary maximum rate set : 24 23 22 Hours Remaining in Day to Refeed Withheld Enteral Formula (Due to Feeding on Hold for Test or Procedure) 21 20 19 18 16 15 14 13 12 11 10 9 8 7 6 5
100 95 90 85 104 99 94 89 80 75 70 65 60 55 50 45 40 35 30 25 20 15
Color Key:
21 16 47 42 37 31 26 83 78 73 68 63 57 52 109 104 98 93 87 82 76 71 65 60 55 49 44 38 33 27 22 16 114 109 103 97 91 86 80 74 69 63 57 51 46 40 34 29 23 17 120 114 108 102 96 90 84 78 72 66 60 54 48 42 36 30 24 18 126 120 114 107 101 95 88 82 76 69 63 57 51 44 38 32 25 19 133 127 120 113 107 100 93 87 80 73 67 60 53 47 40 33 27 20 141 134 150 143 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 127 120 135 128 144 136 150 146 150 150 150 150 150 150 150 150 150 150 150 150 150 150 113 106 99 92 85 78 71 120 113 105 98 90 83 75 128 120 112 104 96 88 80 137 129 120 111 103 94 86 64 56 49 42 35 68 60 53 45 38 72 64 56 48 40 77 69 60 51 43 28 21 30 23 32 24 34 26
White=Tolerated by J Tube
37 28 83 74 65 55 46 148 138 129 120 111 102 92 150 150 140 130 120 110 100 90 80 70 60 50 40 30 150 150 150 142 131 120 109 98 87 76 65 55 44 33 150 150 150 150 144 132 120 150 150 150 150 150 147 133 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150
4
150 150 150 150 150 150 150 150 150 150 150
3
150 150 150 150 150 150 150 150 150 150 150
2
150 150 150 150 150 150 150 150 150 150 150 108 96 84 72 60 120 107 93 80 67 135 120 105 90 75 150 137 120 103 86 150 150 140 120 100 150 150 150 144 120 150 150 150 150 150 150 150 150 150 150 150 150 150 150 150 48 36 53 40 60 45 69 51 80 60 96 72 120 90 150 120 150 150
Green=Arbitrary Maximum Rate Tolerated by J Tube
150 150 150 150 150 150 150
1
150 150 150 150 150 150 150 150 150 150 150
Today
’
s EN Volume
Reduce Deficit with EN: Volume-Based Feeding
%Goal kcals overall 81% → 93% Calorie deficit -1934 kcal → -776 kcal %Goal kcals/day Uninterrupted EN No difference (102-103%) Interrupted EN 61% → 95% (Compliance in only a third of pts ) SA McClave, DK Heyland [JPEN 2011;35(1):134-135]
Reduce Deficit with EN: Top-Down Therapy
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Come out at the start with guns blazing!! Rapid advancement (start at goal) Initiate prokinetics Volume-based feeds Chart cumulative caloric balance Small peptide formula Protein supplements Small bowel feeds Elevate head of bed
• •
Back off as tolerance develops Example: Canadian Pep-Up Study Top Down Goal EN calories 59% →83% ( p<0.02
) Conventional Heyland, McClave [JPEN 2010;34(2):208] #2
#3
Reduce Deficit With EN:
Use of Nurse-Driven EN Protocols
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Elements Tube access Cal balance Rate ramp-up Elevate HOB GRVs Oral care Prokinetics
• •
How to enforce?
Impact on outcome?
Nurse
’
s hand on spigot!
Reduce Deficit With EN: Use of EN Protocols
Studies (year) Design Feed Rx Outcome Taylor (1999) Pinilla (2001) Martin (2004) Doig (2008) 4 1 2 3 PRCT PRCT PRCT PRCT 37 →59% 70 → 76% 2.16→1.6 d to EN ↓Infect, complics, LOS no ∆ ↓Mortality, hosp LOS 1.37→0.75 d to EN no ∆ Spain (2001) 5 Arabi (2004) 6 Barr (2004) 7 B/A Implt 52→68% (nutrit endpts only) B/A Implt 53.9→64.5% no ∆ B/A Implt 68→78% pts on EN ↓Mortality, durat MV 1 CCM 1999;27:2525 2 JPEN 2001;25:81 3 CMAJ 2004;170:197 4 JAMA 2008;300:2731 5 JPEN 1999;23:288-92 6 NCP 2004;19:523 7 Chest 2004;125:1446
Initiating and Enforcing a New EN Protocol
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Prospective interventional study (n=5800 ICU days) NUTSIA Protocol over 3 three-month periods (2005, 2006, 2007) Before Protocol After Protocol With Enforcement (n=198 pts) (n=179 pts) (n=195 pts)
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Results Rx (kcal/kg/d) 11.4 +7.9 13.9 +8.0 15.4 +9.6 ** ICU kcal balance -7180 +5008 -6133 +3854 -5568 +5194 ** Hosp LOS (days) 31.1 +52.2 24.1 +21.0
23.2 +22.1** Soguel L, Revelly JP, Berger MM (CCM 2012;40;1-7)
#4
Reduce Deficit with EN: Modify Existing Protocols
• •
American Society of Anesthesiologists 2011 1 Practice Guidelines for preoperative fasting in the healthy patients undergoing elective procedure (standard NPO policy): 2 hour fast for clear liquids 6 hour fast for light meals
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Meta Analysis of 22 PRCTs showed no evidence that shortened fluid restriction changed risk of aspiration or morbidity vs standard NPO policy 2 1 Anesthesiology 2011;114: 495-511 2 McLeod Can J Surg 2005
Modifying Protocols:
PRCT Modifying NPO Past MN
Gastric Vol (mean
±
SD) Clear view No. (%) Obscured View No. (%) Regurgitation No. (%) NPO at MN (n = 27) 38
±
40 ml 21 (78%) Clear Liqs 240 ml 2 hr fast (n = 17) 48
±
47 ml 10 (63%) 2 (7%) 1 (4%) 2 (13%) 0 (0%) Formula 240 ml 4 hr fast (n = 24) 29
±
30 ml 17 (74%) 2 (9%) 3 (13%) Formula 240 ml 2 hr fast (n = 25) 70
±
77* ml 10 (40%) * Signif P value 0.042
0.026
9 (36%) * 1 (4%) 0.035
0.470
SA McClave, CC Lowen (JPEN 2001;25:S14)
Reduce Deficit with EN: Nutrition Bundle
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Bundle: New concept in ICU care Set of few (5-7) short action statements Strength comes from doing all actions on the list
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Full compliance with bundle actions improves outcome
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Bundles derived in directed way Review of literature → derive guidelines → pick bundle elements → intervention trial
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Effective bundles developed for: VAP, DVT, Pressure Sores, Surgical Site Infection, BSIs Could a bundle be developed for Nutrition therapy?
Reduce Deficit with EN: Nutrition Bundle
Targeted MD Education PRCT with 2 Trauma Teams
• • • • • •
Posted daily patient cumulative caloric deficit Immediate feeding tube placement for mech ventilated patients Elimination of clear liquid diet orders (order full liquids instead) Pre-op and post-op reduction of NPO fasting period Volume-based feeding Minimize fasting period before diagnostic tests GA Franklin, SA McClave (JPEN 2007; 31:S7-8)
Reduce Deficit with EN: Nutrition Bundle
Mean NPO days Mean Clear Liq days Mean Caloric Deficit Mean % Goal kcal infused Target Team (n=66) 2.44 (+/-1.3)d 0.14 (+/-0.8)d * -6795.8 kcal * 30.1 (+/-0.3)% * Control Team (n=55) 2.85 (+/-1.8)d 0.62 (+/-0.8)d -8817 kcal 22.2 (+/-0.2)% ICU days Vent days MOF SOFA Score Infection ( % patients ) 3.5 (+/-5.6)d 1.6 (+/-3.7)d 0.20 (+/-0.8) 10.6% * # # 5.2 (+/-6.8)d 2.8 (+/-5.0)d 0.45 (+/-0.1) 23.6% GA Franklin, SA McClave (JPEN 2007; 31:S7-8) * p < 0.05, # p = 0.13
How Much Should Patients Be Fed?
Some studies upset the apple cart….
Can We Dismiss Some Studies?
Is There Some Fatal Flaw? These studies make me so nervous… Example: Arabi Study JPEN 2010;34(3):280
Artifactual Error by Confounding Factor:
Hospital Mortality (OR= Odds Ratio) Outcome (tertiles) 1 st 2 nd 3 rd Heyland Signif Arabi 1 All ICU patients 1.00
1.23
1.99
p=0.02
Heyland 2 All ICU patients 1.00
1.22
1.28
[ Exclude days of exclusive PO diet (no all PO) ] p=0.0005
No all PO days NRx >4d, no all PO NRx >12d, no all PO 1.00
1.00
1.00
1.08
0.77
0.69
1.04
0.73
0.68
p=NS p<0.0001
p=0.003
1 JPEN 2010;34(3):280 2 CCM 2011;39(12):1
Trophic vs Full Feeds
ARDSNet Multi-Center PRCT Todd Rice 80% Goal calories ALI/ARDS patients on MV Trophic 20cc/hr x 6days (n=508) vs Full feeds (n=492) No difference: Mortality, vent-free days, MOF, or infection 25% Goal calories jama.ama-assn.org (Feb 9, 2012)
Response to Article: Recent Memo
“
Initial Trophic vs Full Enteral Feeding in Patients With Acute Lung Injury
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The ARDSNet Multicenter EDEN Randomized Trial Rice T, et al JAMA 2012;307(8):1-9 Message sent from member of Surviving Sepsis Campaign (SSC) Committee (who are revising their guidelines) to SCCM/ASPEN Guidelines Committee member August 2012:
“The proposed recommendation on enteral nutrition support may need modification. The recent ARDSNet study, as well as earlier studies, suggest that full enteral calorie/protein may not be necessary and could possibly be harmful if given in the first week of critical illness. We recommend that in the new version of the SSC guidelines, feeding should begin in 5 to 7 days rather than 48 hours.
”
Does This Study Conflict With the Literature?
Does This Study Conflict With the Literature?
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Early vs. Delayed EN
Infection PE Marik, GP Zaloga (CCM 2001;29:2264)
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Does This Study Conflict With the Literature?
EN vs Standard Rx (no specialized nutrition Rx) 3,4 Lewis 1,2 – Elective surgery and surgery critical care Reduction infections by 28% (RR=0.72, p=0.03) Reduction hospital LOS by 0.84 days (p=0.001) Reduction mortality 6.8% to 2.4% (p=0.03) Pupelis 3 – Severe acute pancreatitis post-op after complications Reduction in mortality by 74% (RR=0.26, p=0.06) SJ Lewis (BMJ 2001;323:1) 1 (J Gastro Surg 2009;13:569) 2 3 SA McClave (JPEN 2006;30:143)
Does This Study
•
Conflict With the Literature?
Effect of Nurse-driven EN protocols Studies (year) Design Feed Rx Outcome Taylor (1999) Pinilla (2001) Martin (2004) Doig (2008) 4 1 2 3 PRCT PRCT PRCT PRCT 37 →59% 70 → 76% 2.16→1.6 d to EN ↓Infect, complics, LOS no ∆ ↓Mortality, hosp LOS 1.37→0.75 d to EN no ∆ Spain (2001) 5 Arabi (2004) 6 Barr (2004) 7 B/A Implt 52→68% (nutrit endpts only) B/A Implt 53.9→64.5% no ∆ B/A Implt 68→78% pts on EN ↓Mortality, durat MV 1 CCM 1999;27:2525 2 JPEN 2001;25:81 3 CMAJ 2004;170:197 4 JAMA 2008;300:2731 5 JPEN 1999;23:288-92 6 NCP 2004;19:523 7 Chest 2004;125:1446
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How Do We Resolve This?
Why would trophic feeds work?
25% Goals calories is sufficient Dose is less important Early initiation more important Minimizing interruptions important Less fluids in ARDS important 1 BMI range less nutrition effect 2 Findings unique to this population?
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Is doing nothing just as good? No!!
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How does this study affect my practice?
Start early Avoid interruptions Aggressive EN Rx, unless intolerance Avoid setting low target at outset BMI 25-30 BMI 30-35 1 T Rice (JAMA 2012) 2 C Alberda (Int Care Med 2009)
Looking Toward Building Nutrition Therapy at Your Institution
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Build EN program, get involved, re-evaluate policies
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Protocols help move process in the right direction
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Focus on issues optimizing delivery of EN, with judicious use of PN
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Have skill set, expertise, strategies in place to activate
•
Take advantage of opportunities to deliver early EN