1. FELANPE Asuncion, October 2010 Prof. Rémy Meier MD University Hospital Liestal, Switzerland Enteral and Parenteral Guidelines ESPEN

2. Research Clinical results Guidelines

3. Definition of Guidelines Clinical guidelines are defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care and for specific clinical circumstances

4. Aims of the ESPEN-Guidelines The ESPEN-Guidelines „Enteral and Parenteral Nutrition“ aim to assist clinical practitioners, dietitians and nurses who provide enteral and parenteral nutrition support to patients in all care settings as well as to give information to decision- makers in the health care system

5. Methodology for the development of the ESPEN Guidelines on enteral and parenteral nutrition Systemic reviewSystemic review Evidence basedEvidence based Consensus basedConsensus based

6. Manpower EN 13 disease-specific working groups13 disease-specific working groups 88 experts in clinical nutrition88 experts in clinical nutrition 20 countries20 countries

7. Manpower PN 11 disease-specific working groups11 disease-specific working groups 87 experts in clinical nutrition87 experts in clinical nutrition 16 countries16 countries

8. Evidence gathering Structured literature searchStructured literature search Defined search strategy (including criteria, specific key words)Defined search strategy (including criteria, specific key words) Assessment of the quality and the strength of the literatureAssessment of the quality and the strength of the literature Defining the level of evidenceDefining the level of evidence Defining the grade of recommendationDefining the grade of recommendation

9. According to the criteria of SIGN (Scottish Intercollegiale Guideline Network, No 39, 1999) and According to the criteria of AHCPR (Agency for Health Care Policy and Research, No 92-0023, 1993) According to the criteria of AHCPR (Agency for Health Care Policy and Research, No 92-0023, 1993) The quality and strength of the supporting evidence was graded

10. Grades of recommendations and levels of evidence Grades of re- commendations Levels of evidenceRequirement A Ia Ia Ib Ib Meta-analysis of randomized controlled trials At least one randomized controlled trial B IIa IIa IIb IIb III III At least one well-designed controlled trial without randomization At least one other type of well-designed, quasi-experimental study Well-designed non-experimental descriptive studies such as comparative studies, correlation studies, case-control studies C IV IV Expert options and/or clinical experience of respected authorities

11. The recommendations were not only based on the evidence levels of the studies but also on the judgement of the working group concerning the consistency, clinical relevance and validity of the evidence

12. The preparation and publication of the ESPEN-Guidelines on Enteral and Parenteral Nutrition were exclusively funded by ESPEN

13. Problems with Recommentations ESPEN Guidelines 3 recommentations level A-C but others have 4-5 levels of recommendations A-E

14. ESPEN-EN-Guidelines 2006 Surgery I Recommendation A Preoperative fasting from midnight is Preoperative fasting from midnight is unnecessary in most patients unnecessary in most patients Interruption of nutritional intake is Interruption of nutritional intake is unnecessary after surgery in most patients unnecessary after surgery in most patients Use nutritional support in patients with Use nutritional support in patients with severe nutritional risk for 10-14 days prior severe nutritional risk for 10-14 days prior to major surgery even if surgery has to be to major surgery even if surgery has to be delayed. delayed.

15. Nutritional risk refers to at least one idem: -Weight loss > 10-15% within 6 months - BMI < 18.5 kg/m2 - Subjective Global Assessment Grade C -Serum albumin <30 g/l (with no evidence of hepatic or renal (with no evidence of hepatic or renal dysfunction) dysfunction)

16. ESPEN-EN-Guidelines 2006 Surgery II Recommendation A Patients undergoing surgery who are considered to have no specific risk for aspiration, may drink clear fluids until 2 h before anaesthesia. Solids are allowed until 6 h before anaesthesiaPatients undergoing surgery who are considered to have no specific risk for aspiration, may drink clear fluids until 2 h before anaesthesia. Solids are allowed until 6 h before anaesthesia Initiate normal food intake or enteral feeding early after gastrointestinal surgeryInitiate normal food intake or enteral feeding early after gastrointestinal surgery Oral intake, including clear liquids, can be initiated within hours after surgery to most patients undergoing colon resectionsOral intake, including clear liquids, can be initiated within hours after surgery to most patients undergoing colon resections

17. ESPEN-EN-Guidelines 2006 Surgery III Recommendation A Apply tube feeding in patients in whom early oral nutrition can not be initiated, with special regard to those - undergoing major head and neck orApply tube feeding in patients in whom early oral nutrition can not be initiated, with special regard to those - undergoing major head and neck or gastrointestinal surgery for cancer - with severe trauma - with obvious undernutrition at the time of surgery gastrointestinal surgery for cancer - with severe trauma - with obvious undernutrition at the time of surgery Initiate tube feeding for patients in need within 24 h after surgeryInitiate tube feeding for patients in need within 24 h after surgery Placement of a needle catheter jejunostomy orPlacement of a needle catheter jejunostomy or naso-jejunal tube is recommended for all candidates for TF undergoing major abdominal surgery

18. ESPEN-EN-Guidelines 2006 Surgery IV Recommendation A Placement of a needle catheterPlacement of a needle catheter jejunostomy or naso-jejunal tube is recommended for all candidates for TF undergoing major abdominal surgery. Use EN preferably withUse EN preferably with immuno-modulating substrates immuno-modulating substrates (arginine, ω-3 fatty acids and nucleotides) perioperatively independent of (arginine, ω-3 fatty acids and nucleotides) perioperatively independent of the nutritional risk for those patients the nutritional risk for those patients

19. This patients are specified Those patients who benefit are patients - undergoing major neck surgery for cancer (laryngectomy, pharyngectomy) (laryngectomy, pharyngectomy) -undergoing major abdominal cancer surgery (oesophagectomy, gastrectomy, and pancreato-duodenectomy) (oesophagectomy, gastrectomy, and pancreato-duodenectomy) - after severe trauma

20. ESPEN-PN-Guidelines 2009 What was new ?What was new ? The recommendations of the EN guidelines were taken and the evidences of parenteral nutrition of each topic were added

21. ESPEN-PN-Guidelines 2009 Surgery I The main goals of perioperative nutritional support are to minimize negative protein balance by avoiding starvation, with the purpose of maintaining muscle, immune, and cognitive function, and to enhance postoperative recovery!

22. ESPEN-PN-Guidelines 2009 Surgery II Recommendation A Preoperative parenteral nutrition isPreoperative parenteral nutrition is indicated in severely undernourished patients who cannot be adequately orally or enterally fed Postoperative parenteral nutrition is beneficial in undernourished patients in whom enteral nutrition is not feasable or not toleratedPostoperative parenteral nutrition is beneficial in undernourished patients in whom enteral nutrition is not feasable or not tolerated

23. ESPEN-PN-Guidelines 2009 Surgery III Recommendation A Postoperative parenteral nutrition is beneficial in patients with postoperative complications impairing gastrointestinal function who are unable to receive and absorb adequate amounts of oral/enteral feeding for at least 7 daysPostoperative parenteral nutrition is beneficial in patients with postoperative complications impairing gastrointestinal function who are unable to receive and absorb adequate amounts of oral/enteral feeding for at least 7 days

24. ESPEN-PN-Guidelines 2009 Surgery IV Recommendation A In patients who require postoperative artificial nutrition, enteral feeding or a combination of enteral and supplementary parenteral feeding is the first choiceIn patients who require postoperative artificial nutrition, enteral feeding or a combination of enteral and supplementary parenteral feeding is the first choice Weaning from parenteral nutrition is not necessaryWeaning from parenteral nutrition is not necessary

25. Recommendations on Enteral Nutrition Total number of recommendations 226Total number of recommendations 226 Recommendations A= 55(25%)Recommendations A= 55(25%) Redommendations B = 39(17%)Redommendations B = 39(17%) Recommendations C= 132 (58%)Recommendations C= 132 (58%)

26. Recommendations on Parenteral Nutrition Total number of recommendations 300Total number of recommendations 300 Recommendations A= 48(16%)Recommendations A= 48(16%) Redommendations B = 94(28%)Redommendations B = 94(28%) Recommendations C= 158 (56%)Recommendations C= 158 (56%)

27. Over 50% of the recommendations are only C „Expert opinions and/or clinical experience of respected authorities“ Problem!

28. ASPEN Guidelines 1993 ESPEN 2006/2009 - Recommendation A = 16% 25% 16% - Recommendation B = 29% 17%28% - Recommendation C = 55% 58%56% What has changed? Nothing!!!!!!

29. There is still a lack of good clinical studies in clinical nutrition!!

30. The guidelines do provide evience- based information about some specific problems like timing, dosing, composition and route of application, and under which conditions limitation or withdrawal of nutritional support like other therapies might be adequate but they also show where additional studies are needed

31. Guidelines shows were noGuidelines shows were no enough evicence for a clear recommendation is available enough evicence for a clear recommendation is available This can help to design new studies to fill in the missing informationThis can help to design new studies to fill in the missing information Genereation of new hypothesis using guidelines

32. Db, controlled, randomized trialsDb, controlled, randomized trials Adaequate sample sizeAdaequate sample size Clear endpointsClear endpoints Single- or multicenter trialSingle- or multicenter trial Good clinical trials

33. Selection of endpoints is crucial!Selection of endpoints is crucial! Mortality is difficult in nutritinal studiesMortality is difficult in nutritinal studies (high number of patients needed) (high number of patients needed) Morbidity is often usedMorbidity is often used Changes in body compositionChanges in body composition but but QoL, function, mood, costs …. can be important in special situationQoL, function, mood, costs …. can be important in special situation Endpoints

34. Nutritional screening of all patients Nutritional support using guidelines Regular audits Regular audits Continuous training Monitoring Implementation of guidelines

35. GuidelineApproach Outcome Patients at risk ScreeningAssessment PRCT

36. 489 ICU patients in 14hospitals RCT489 ICU patients in 14hospitals RCT 7 – EBM Guidelines7 – EBM Guidelines –Early EE –Preferably EN 7 - Controls7 - Controls % days days p=0.047 p=0.002 n.s. Multicenter clinical trial of algorithms for critical-care enteral and parenteral therapy (ACCEPT) Martin et al, CMAJ 2004 Improved outcome Improved outcome More EN More EN Less PE Less PE

37. Appropriate use of PN First monitoring Implementation of clinical practice guidelinesFirst monitoring Implementation of clinical practice guidelines Control monitoringControl monitoring Appropriate / inappropriate wasAppropriate / inappropriate was pre-defined pre-defined

38. Results Appropriate PN First monitoringFirst monitoring - with experienced 67% staff support - without experienced 41% (PN days↑53%) staff support (costs↑ 36%) - with experienced 67% staff support - without experienced 41% (PN days↑53%) staff support (costs↑ 36%) Control monitoring80% (costs↓ 50%)Control monitoring80% (costs↓ 50%) Schneider, NCP, 2006

39. Summary The guidelines do provide evience-based information about specific problems like timing, dosing, composition and route of application They also show where additional studies are needed and under which conditions limitation or withdrawal of nutritional support like other therapies might be adequate

40. The ESPEN-Guidelines are separate for enteral- and parenteral nutritionThe ESPEN-Guidelines are separate for enteral- and parenteral nutrition It would be easier to have combined guidelinesIt would be easier to have combined guidelines Limitations

41. Conclusion The ESPEN guidelines on enteral and parenteral nutrition reflect the current medical knowledge in the field of enteral and parenteral nutrition therapy and summarize the evidence when enteral nutrition is indicated and which goals can be reached in regard to nutritional state, quality of life and outcome

42. Publication Clinical Nutrition Vol 25 (2),Clinical Nutrition Vol 25 (2), April 2006 (Enteral) April 2006 (Enteral) Clinical Nutrition Vol 28, August 2009Clinical Nutrition Vol 28, August 2009(Parenteral) www.espen.org/education/www.espen.org/education/ guidelines.htm