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Nutrition as Therapy: Strategies for the Delivery of Enteral Nutrition

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.

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Nutrition as Therapy: Strategies for the Delivery of Enteral Nutrition

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  1. 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

  2. Disclosures As it pertains to this CME activity, I have the following disclosures to report: • Grant/Research Support-Covidien, Nestle • Consultant-Nestle, Abbott, Covidien • Speaker’s Bureau-Nestle, Abbott Stephen A. McClave, MD

  3. What’s Driving Nutrition Therapy? Nutrition Rx This Way Caloric deficit; Timing of EN initiation; Who benefits from EN Rx?

  4. Effect of Caloric Deficit 10,000 kcal Bartlett (1982) 1 Mortality increases 27% →76% Mault (2000) 2 Durat MV increases 10 → 20 days ICU LOS increases 16 → 25 days 5,000 kcal Villet (2005) 3 Hosp LOS (p=0.0001) Complics (p=0.0003) Infections (p=0.004) Durat MV (p=0.0002) 4,000 kcalDvir, 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) Ramp-Up Caloric Deficit * p<0.05 1 Surg 1982;92:771 2 JPEN 2000;24:S4 3 CCM 2005 4 Clin Nutrit 2006;25:37

  5. 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

  6. 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

  7. Who Benefits from Enteral Nutrition? RxEffect on High Risk Pts p=0.01 Heyland DK (Crit Care 2011;6:1)

  8. Value of ENin the ICU • Rationale: Prevents gut permeability and cytokine storm Stimulates anti-inflammatory Th-2 CD4 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

  9. EN is hard work! Providing EN in ICU is Difficult • “Physician-directed Malnutrition” QA Monitor over 3 mos (n= 1192)1 21.9% were NPO > 3 days Durat NPO mean 5.2d (range 0-16) • Anticipate under-delivery of EN Study Required Intended Actual Ibrahim 2 100% 100% 27.9% McClave3 100% 65% 50% Arabi4 100% 90-100% 71.4% • University of Louisville experience (% goal delivered) CCU/Neuro ICU 50% MICU 80% SICU 20% Burn ICU 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

  10. Value of PNin the ICU • 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)

  11. EPaNIC Trial What is Best Way to Reduce Caloric Deficit? Van den Berghe Europe USA Casaer MP, Van den Berghe G (NEJM 2011;365:506)

  12. SCCM/ASPEN (USA) vs ESPEN (Europe) versus

  13. Results of EPaNIC Study • PRCT 4640 adult ICU pts multicenter Received 2009 Stoutenbeek Award for study design All pts started on EN, tight glucose control • Results Early PN (ESPEN) Late PN (ASPEN) (n=2312) (n=2328) Infection 26.2% 22.8% * ICU LOS 4.0 d 3.0 d * Hosp LOS 14.0 d 12.0 d * Durat CRRT 10.0 d 7.0 d * MV > 2 days 40.2% 36.3% * Hosp mortality 10.9% 10.4% (p=NS) ICU dschg alive 71.7% 75.2%* Healthcare cost 17,973 E 16,863 E * * p<0.05 MP Casear, G Van Den Berghe (NEJM 2011;365:506)

  14. Swiss Study Supplemental PN 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 Results (EN vs SPN) Coefficient Signif New infection -0.27 0.019 Mech vent hrs -87.4 0.001 Hosp LOS -2.70d 0.009 Key issues: Wait longer to add PN (at 72 hrs) Only add if EN feeds <60% goal M Berger, C Pichard (24th ESICM Congress, Berlin, Germany, October 1-5, 2011)

  15. Issue of Supplemental PN What have we learned? Re-Analysis of EPaNIC Study in Patients With Greatest Dz Severity • Tremendous adverse effect from PN use outside the setting of intestinal failure APACHE II vs Mort, LOS, MOF < 10 10-20 20-30 >30 Favors Early PN Favors Late PN Greet Van den Berghe (DDW 2012 Presentation)

  16. 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

  17. Reduce Deficit with EN:Volume-Based Feeding #1 Today’s Total Volume Rate-Based Feeding Volume-Based Feeding

  18. Chart to Calculate Adjusted Rate Volume-Based Protocol Rate for hours remaining EN Vol • Arbitrary maximum rate set : • Stomach (280 mL/hr) • Small bowel (150 mL/hr)

  19. Reduce Deficit with EN: Volume-Based Feeding Today’s EN Volume %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]

  20. #2 Reduce Deficit with EN: Top-Down Therapy • 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 Goal EN calories 59%→83% (p<0.02) Top- Down Conventional Heyland, McClave [JPEN 2010;34(2):208]

  21. Use of Nurse-Driven EN Protocols #3 Reduce Deficit With EN: • Elements Tube access Rate ramp-up Elevate HOB GRVs Oral care Prokinetics Cal balance • How to enforce? • Impact on outcome? Nurse’s hand on spigot!

  22. Reduce Deficit With EN: Use of EN Protocols Studies (year) Design Feed Rx Outcome Taylor (1999)1 PRCT 37→59% ↓Infect, complics, LOS Pinilla (2001)2 PRCT 70 → 76% no ∆ Martin (2004)3 PRCT 2.16→1.6 d to EN ↓Mortality, hosp LOS Doig (2008)4 PRCT 1.37→0.75 d to EN no ∆ Spain (2001)5 B/A Implt 52→68% (nutrit endpts only) Arabi (2004)6 B/A Implt 53.9→64.5% no ∆ Barr (2004)7 B/A Implt 68→78% pts on EN ↓Mortality, durat MV 1CCM 1999;27:2525 2JPEN 2001;25:81 3CMAJ 2004;170:197 4JAMA 2008;300:2731 5JPEN 1999;23:288-92 6NCP 2004;19:523 7Chest 2004;125:1446

  23. Initiating and Enforcing a New EN Protocol • 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) • 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)

  24. #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 • 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

  25. Modifying Protocols:PRCTModifying NPO Past MN SA McClave, CC Lowen (JPEN 2001;25:S14)

  26. #5 #5 Reduce Deficit with EN: Nutrition Bundle • Bundle: New concept in ICU care Set of few (5-7) short action statements Strength comes from doing all actions on the list Full compliance with bundle actions improves outcome • Bundles derived in directed way Review of literature → derive guidelines → pick bundle elements → intervention trial • Effective bundles developed for: VAP, DVT, Pressure Sores, Surgical Site Infection, BSIs • Could a bundle be developed for Nutrition therapy?

  27. Reduce Deficit with EN: Nutrition Bundle Targeted MD Education • 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 PRCT with 2 Trauma Teams GA Franklin, SA McClave (JPEN 2007; 31:S7-8)

  28. Reduce Deficit with EN:Nutrition Bundle Target Team Control Team (n=66) (n=55) Mean NPO days 2.44 (+/-1.3)d 2.85 (+/-1.8)d Mean Clear Liq days 0.14 (+/-0.8)d * 0.62 (+/-0.8)d Mean Caloric Deficit -6795.8 kcal * -8817 kcal Mean % Goal kcal infused 30.1 (+/-0.3)% * 22.2 (+/-0.2)% ICU days 3.5 (+/-5.6)d # 5.2 (+/-6.8)d Vent days 1.6 (+/-3.7)d # 2.8 (+/-5.0)d MOF SOFA Score 0.20 (+/-0.8) * 0.45 (+/-0.1) Infection ( % patients ) 10.6% 23.6% GA Franklin, SA McClave (JPEN 2007; 31:S7-8) *p < 0.05, # p = 0.13

  29. How Much Should Patients Be Fed? Some studies upset the apple cart….

  30. Example: Arabi Study Can We Dismiss Some Studies? Is There Some Fatal Flaw? These studies make me so nervous… JPEN 2010;34(3):280

  31. Artifactual Error by Confounding Factor: Outcome (tertiles) 1st 2nd 3rd 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 p=0.0005 [ Exclude days of exclusive PO diet (no all PO) ] No all PO days 1.00 1.08 1.04 p=NS NRx >4d, no all PO 1.00 0.77 0.73 p<0.0001 NRx >12d, no all PO 1.00 0.69 0.68 p=0.003 Hospital Mortality (OR= Odds Ratio) Heyland 1 JPEN 2010;34(3):280 2 CCM 2011;39(12):1

  32. 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)

  33. Response to Article: Recent Memo “Initial Trophicvs Full Enteral Feeding in Patients With Acute Lung Injury” 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.”

  34. Does This Study Conflict With the Literature?

  35. Does This Study Conflict With the Literature? Early vs. Delayed EN Infection PE Marik, GP Zaloga (CCM 2001;29:2264)

  36. 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)

  37. Does This Study Conflict With the Literature? Effect of Nurse-driven EN protocols Studies (year) Design Feed Rx Outcome Taylor (1999)1 PRCT 37→59% ↓Infect, complics, LOS Pinilla (2001)2 PRCT 70 → 76% no ∆ Martin (2004)3 PRCT 2.16→1.6 d to EN ↓Mortality, hosp LOS Doig (2008)4 PRCT 1.37→0.75 d to EN no ∆ Spain (2001)5 B/A Implt 52→68% (nutrit endpts only) Arabi (2004)6 B/A Implt 53.9→64.5% no ∆ Barr (2004)7 B/A Implt 68→78% pts on EN ↓Mortality, durat MV 1CCM 1999;27:2525 2JPEN 2001;25:81 3CMAJ 2004;170:197 4JAMA 2008;300:2731 5JPEN 1999;23:288-92 6NCP 2004;19:523 7Chest 2004;125:1446

  38. How Do We Resolve This? BMI 25-30 BMI 30-35 • 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? • Is doing nothing just as good? No!! • How does this study affect my practice? Start early Avoid interruptions Aggressive EN Rx, unless intolerance Avoid setting low target at outset 1 T Rice (JAMA 2012)2 C Alberda (Int Care Med 2009)

  39. Looking Toward Building Nutrition Therapy at Your Institution • Build EN program, get involved, re-evaluate policies • Protocols help move process in the right direction • Focus on issues optimizing delivery of EN, with judicious use of PN • Have skill set, expertise, strategies in place to activate • Take advantage of opportunities to deliver early EN

  40. Questions? Thank you for your time today

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