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Daren K. Heyland MD Professor of Medicine Queen’s University, Kingston, ON Canada

Daren K. Heyland MD Professor of Medicine Queen’s University, Kingston, ON Canada On behalf of the Canadian Critical Care Nutrition Clinical Practice Guidelines Committee. The 2013 Canadian Critical Care Nutrition Clinical Practice Guidelines: What are the Latest Recommendations?. 1.

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Daren K. Heyland MD Professor of Medicine Queen’s University, Kingston, ON Canada

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  1. Daren K. Heyland MD Professor of MedicineQueen’s University, Kingston, ON Canada On behalf of the Canadian Critical Care Nutrition Clinical Practice Guidelines Committee The 2013 Canadian Critical Care Nutrition Clinical Practice Guidelines: What are the Latest Recommendations? 1

  2. Disclosures • I have received speaker honoraria and/or I have been paid from grants from the following companies: • Nestlé • Fresenius Kabi • Baxter • Abbott 1

  3. Learning Objectives • Better understand the process by which CPGs are developed • Become familiar with recent randomized nutrition trials in • critically ill adult patients • Enteral Fish oils • PN and type of Lipids • New Sections • Review the updated analyses and recommendations of the • Canadian CPGs 1

  4. 2005 update • update • update • 2013 update • Orginally published in 2003 • Summarizes 198 trials studying 21283 patients • 34 topics 17 recommendations www.criticalcarenutrition.com

  5. Guideline Development evidence integration of values + Effect size Confidence Intervals Validity Homogeneity Adequacy of control group Biological plausibility Generalizability Safety Feasibility Cost practice guidelines

  6. Language of Recommendations 1

  7. Inclusion Criteria Updated to 2013 • Randomized controlled trials • Critically ill patients (not elective surgery) • Clinical Outcomes • EMBASE, Medline, Cinhal, reference lists 1

  8. New Evidence 67 new RCTs across 27 topics!

  9. New RCTs per Topic

  10. New RCTs per topic

  11. New Topics (n=10)

  12. Enteral Fish Oils* *Product enhanced with fish oils +borage oils + antioxidants 1

  13. Enteral Fish Oils* *Product enhanced with fish oils +borage oils + antioxidants 2009 Recommendation Based on 5 studies, we recommend the use of enteral formula with fish oils, borage oils, and antioxidants in patients with ALI/ARDS New RCTs = 4 Rice 2011 Grau-Carmona 2011 Thiella 2011 Elamin 2012 + Pontes Arruda 2011 + Stapleton 2011 (fish oil only)

  14. ARDSnet NIH NHLBI Timing of Feeding “Early Trophic” (10 ml/hr) “Early Full” Fast ramp up S U P P L E M E N T N-3 + GLA + Antioxidants (Module delivered as bolus bid) Control Standard EN (480 cal/ 20 g pro)

  15. OMEGA: 60-Day Mortality P=0.14 P=0.14 P=0.05 bolus: dilute effect? 50% pts underfed (trophic) protein in placebo include but analyze without Rice et al JAMA Oct 2011

  16. 11 Spanish ICUs • 89 patients with diagnosis of Sepsis on admission • Randomized to: • Fish Oil/Borage Oil formula OR • Standard polymeric formula • Outcomes: new organ dysfunction Grau-Carmona Clin Nutr 2011

  17. Clinical Outcomes Fish Oils: Trend towards lower SOFA scores (NS) First multicentre study to use “usual care” in control group…….no effect on mortality Grau-Carmona Clin Nutr 2011

  18. 89 patients from 5 centres in US • Mechanically ventilated patients with Acute lung injury (ALI) • Randomized to (separate from EN): • BOLUS fish oils 7.5 mls q 6 hrs, 9.75g EPA & 6.75 gm DHA/day • OR • placebo i.e. normal saline X 14 days • EN or PN as per MDs discretion Stapleton CCM 2011

  19. Clinical Outcomes Fish Oils ONLY Bolus Separate from EN X aggregate with RCTs of fish oil, borage oil Stapleton CCM 2011

  20. Fish Oils: Effect on mortality (n = 6) INTERSEPT, Stapleton data not included No effect , statistical heterogeneity! 2009: RR 0.67, 95% CI 0.51, 0.97, p = 0.003

  21. Fish oils: effect on mortality removing bolus RCT (n =5) Significant effect, no statistical heterogeneity!

  22. EN Fish oils with new RCTs • Effect on mortality disappears when bolus study is included • statistical heterogeneity present • Effect on mortality is significant when bolus study excluded • Infections (2 RCTs): no effect • Reduction in ICU LOS still significant (heterogeneity) • Concerns of control group, negative results of large studies 2013 Recommendations Fish Oils/borage oil: Downgraded recommendation to “should be considered” Fish Oils alone: insufficient data

  23. Use of PN and type of lipids 1

  24. EN + PN No change from 2009 we recommend that PN not be started not be started at the same time as EN. Insufficient evidence in those who are not tolerating EN (case by case) Lancet 2012 NEJM 2011 Combined EN + PN Early Supplemental PN vs. Late • used indirect calorimetry • No difference mortality • reduced infections day 4-28 • + Abrishami 2010 • + Chen 2011 • large multicentre • early PN: worse infections, LOS • early PN: no diff mortality • high glucose loading • low risk patients Strongly recommend that early PN & high IV glucose not be used in low risk, short ICU stay Insufficient evidence in those who are not tolerating EN (case by case)

  25. Lipid Free PN? There are no new randomized controlled trials since the 2009 update and hence there are no changes to the recommendation. Recommendation: • Based on 2 level 2 studies, in critically ill patients who are not malnourished, are tolerating some EN, or when parenteral nutrition is indicated for short term use (< 10 days), withholding soy bean emulsions should be considered. • There are insufficient data to make a recommendation about withholding lipids high in soybean oil in critically ill patients who are malnourished or those requiring PN for long term (> 10 days). • Practitioners will have to weigh the safety and benefits of withholding lipids high in soybean oil on an individual case-by-case basis in these latter patient populations.

  26. Ifyou are goingto use PN, whichlipidemulsions? Less Pro-Inflammatory More Pro-Inflammatory Vanek VW, et al. Nutr Clin Pract 2012; 27: 150.

  27. LIPID EMULSIONS Classification ALTERNATIVE LIPID EMULSIONS

  28. What does the evidence show about Alternative Lipid Emulsions in the Critically Ill?

  29. Study Selection Criteria

  30. Overall effect on Mortality of ω-6 ReducingStrategy(n= 12 RCT) Ω-6 SparingStrategieswere associated with a reduction in Mortality (RR= 0.83, 95 % CI 0.62, 1.11, P= 0.20, heterogeneity I2 =0%) Manzanares W, et al. Int Care Med 2013 (in press)

  31. Overall effect on Ventilation Days (n= 5 RCT) Ω-6 SparingStrategieswere associated with a trend towards a reduction in Ventilation Days (WMD -2.57, 95% CI -5.51, 0.37, P=0.09) Manzanares W, et al. Int Care Med 2013 (in press)

  32. Overall effect on ICU Length of Stay (n= 8 RCT) Ω-6 ReducingStrategieswere associated with a trend towards a reduction in ICU LOS (WMD -2.31, 95% CI -5.28, 0.66, P=0.13) Manzanares W, et al. Int Care Med 2013 (in press)

  33. Subgroup Analysis (I) N = 4 RCT

  34. Subgroup Analysis (II) N = 4 RCT

  35. Fish Oil Lipid Emulsions in the Critically Ill Mortality (n= 5 RCT) 0.71 (0.49,1.04) P= 0.08 FO containing lipid emulsions were associated with a trend towards a reduction in mortality RR= 0.71, 95 %CI 0.49-1.04, P= 0.08 Manzanares W, et al. JPEN 2013, in press.

  36. Fish Oil Lipid Emulsions in the Critically Ill Ventilation Days (n= 5 RCT) -1.41 (-3.43,0.61) P= 0.17 FO containing emulsions showed a trend towards reduction in the duration of MV days WMD -1.41, 95% CI -3.43, 0.61, P=0.17 Manzanares W, et al. JPEN 2013, in press.

  37. Which Alternative Lipid Emulsion to Use? • No head to head trials (and not likely to be) • We analyzed our International Nutrition Survey database to evaluate effect of Alt Lipids on outcomes. • Analyzed adjusted for key confounding variables. Edmunds, Heyland (in submission) 1

  38. Which Alternative Lipid Emulsion to Use? Edmunds, Heyland (in submission) 1

  39. Which Alternative Lipid Emulsion to Use? Edmunds, Heyland (in submission) 1

  40. Which Alternative Lipid Emulsion to Use? Fish Oil Olive Oil Lipid Free MCT Soybean Edmunds, Heyland (in submission) 1

  41. PN Type of Lipids 2009 Recommendation There are insufficient data to make a recommendation on the type of lipids to be used in critically ill patients receiving parenteral nutrition. 2013 Recommendation: IV lipids that reduce the load of omega-6 fatty acids/soybean oil emulsions should be considered. There are insufficient data on type of soybean reducing lipids

  42. Other Topics

  43. Summary • Many recent RCTs in area of critical care nutrition • Careful review of the articles is recommended • Recommendations downgraded EN Fish Oils/borage oils PN Glutamine • Recommendations upgraded Probiotics Type of PN lipids • Recommendations do not change Combined AOX PN Selenium and others • New Recommendations PN + EN Glutamine: strongly recommended NOT to be used Early PN vs Delayed PN: Strongly recommend NOT be used Other: Trophic vs full feeds: should NOT be considered Updated recommendations will have an impact on practices in ICU

  44. Acknowledgment Canadian Clinical Practice Guidelines Committee John Muscedere Khursheed Jeejeebhoy Courtney Somers-Balota Dominique Garrel Adam Rahman William Manzanares Paul Wischmeyer Rene Stapleton Todd Rice Andrew Davies Emma Ridley Co Chair Daren Heyland Leah Gramlich John Drover Brian Jurewitsch Carmen Christman Chelsea Corbett Jan Greenwood Michele McCall Gwynne Macdonald Guiseppe Pagliarello Jim Kutsogiannis

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