Impact of early parenteral nutrition completing enteral nutrition in adult critically ill patients (EPaNIC trial): A study protocol and statistical analysis plan for a randomized controlled trial

Trials

Volumn 12, Issue , 2011, Pages

  Casaer, Michaël P ^a   Hermans, Greet ^a   Wilmer, Alexander ^a   Van den Berghe, Greet ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BODY MASS; CALORIC INTAKE; CLINICAL PROTOCOL; CLINICAL STUDY; CRITICALLY ILL PATIENT; ENTERIC FEEDING; FEEDING; FOLLOW UP; HOSPITAL ADMISSION; HOSPITALIZATION; HUMAN; INTENSIVE CARE UNIT; MALNUTRITION; MORBIDITY; MORTALITY; NUTRITIONAL SUPPORT; OUTCOME ASSESSMENT; PARALLEL DESIGN; PARENTERAL NUTRITION; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STATISTICAL ANALYSIS; TREATMENT PLANNING; ADULT; BELGIUM; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRITICAL ILLNESS; INTENSIVE CARE; METHODOLOGY; MULTICENTER STUDY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TIME; TREATMENT OUTCOME;

ADULT; BELGIUM; CRITICAL ILLNESS; ENERGY INTAKE; ENTERAL NUTRITION; HUMANS; INTENSIVE CARE; INTENSIVE CARE UNITS; PARENTERAL NUTRITION; PRACTICE GUIDELINES AS TOPIC; PROSPECTIVE STUDIES; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 78751647183     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-21     Document Type: Article

References (38)

1. Barr J, Hecht M, Flavin KE, Khorana A, Gould MK. Outcomes in critically ill patients before and after the implementation of an evidence-based nutritional management protocol. Chest 2004, 125:1446-1457. 10.1378/chest.125.4.1446, 15078758.
2. Martin CM, Doig GS, Heyland DK, Morrison T, Sibbald WJ. Multicentre, cluster-randomized clinical trial of algorithms for critical-care enteral and parenteral therapy (ACCEPT). CMAJ 2004, 170:197-204. 315525, 14734433.
3. Doig GS, Simpson F, Finfer S, Delaney A, Davies AR, Mitchell I, Dobb G. Effect of evidence-based feeding guidelines on mortality of critically ill adults: a cluster randomized controlled trial. JAMA 2008, 300:2731-2741. 10.1001/jama.2008.826, 19088351.
4. Braunschweig CL, Levy P, Sheean PM, Wang X. Enteral compared with parenteral nutrition: a meta-analysis. Am J Clin Nutr 2001, 74:534-542.
5. Peter JV, Moran JL, Phillips-Hughes J. A metaanalysis of treatment outcomes of early enteral versus early parenteral nutrition in hospitalized patients. Crit Care Med 2005, 33:213-220. 10.1097/01.CCM.0000150960.36228.C0, 15644672.
6. Simpson F, Doig GS. Parenteral vs. enteral nutrition in the critically ill patient: a meta-analysis of trials using the intention to treat principle. Intensive Care Med 2005, 31:12-23. 10.1007/s00134-004-2511-2, 15592814.
7. Reid C. Frequency of under- and overfeeding in mechanically ventilated ICU patients: causes and possible consequences. J Hum Nutr Diet 2006, 19:13-22. 10.1111/j.1365-277X.2006.00661.x, 16448470.
8. Heyland DK, Schroter-Noppe D, Drover JW, Jain M, Keefe L, Dhaliwal R, Day A. Nutrition support in the critical care setting: current practice in canadian ICUs--opportunities for improvement?. JPEN J Parenter Enteral Nutr 2003, 27:74-83. 10.1177/014860710302700174, 12549603.
9. Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hébert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med 2009, 360:1283-1297. 10.1056/NEJMoa0810625, 19318384.
10. Desachy A, Clavel M, Vuagnat A, Normand S, Gissot V, Francois B. Initial efficacy and tolerability of early enteral nutrition with immediate or gradual introduction in intubated patients. Intensive Care Med 2008, 34:1054-9. 10.1007/s00134-007-0983-6, 18210092.
11. Friedman B, Stil J. Ability to predict enteral feeding of patients admitted to an intensive care unit (ICU): a subanalysis of prelminary data from the ICU intravenous pantprazole study. Crit Care Med 2002, 30(12):S232.
12. Rubinson L, Diette GB, Song X, Brower RG, Krishnan JA. Low caloric intake is associated with nosocomial bloodstream infections in patients in the medical intensive care unit. Crit Care Med 2004, 32:350-357. 10.1097/01.CCM.0000089641.06306.68, 14758147.
13. Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux RNM, Delarue J, Berger MM. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr 2005, 24:502-509. 10.1016/j.clnu.2005.03.006, 15899538.
14. Dvir D, Cohen J, Singer P. Computerized energy balance and complications in critically ill patients: an observational study. Clin Nutr 2006, 25:37-44. 10.1016/j.clnu.2005.10.010, 16321459.
15. Dhaliwal R, Jurewitsch B, Harrietha D, Heyland DK. Combination enteral and parenteral nutrition in critically ill patients: harmful or beneficial? A systematic review of the evidence. Intensive Care Med 2004, 30:1666-1671. 10.1007/s00134-004-2345-y, 15185069.
16. Mcclave SA, Lowen CC, Kleber MJ, Nicholson JF, Jimmerson SC, McConnell JW, Jung LY. Are patients fed appropriately according to their caloric requirements?. JPEN J Parenter Enteral Nutr 1998, 22:375-381. 10.1177/0148607198022006375, 9829611.
17. Grau T, Bonet A, Rubio M, Mateo D, Farre M, Acosta JA, Blesa A, Montejo JC, de Lorenzo AG, Mesejo A. Liver dysfunction associated with artificial nutrition in critically ill patients. Crit Care 2007, 11:R10. 10.1186/cc5670, 2147066, 17254321.
18. Van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in the critically ill patients. N Engl J Med 2001, 345:1359-1367. 10.1056/NEJMoa011300, 11794168.
19. Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van D, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet 2009, 373:547-556. 10.1016/S0140-6736(09)60044-1, 19176240.
20. Hermans G, De JB, Bruyninckx F, Van den Berghe G. Clinical review: Critical illness polyneuropathy and myopathy. Crit Care 2008, 12:238. 10.1186/cc7100, 2646339, 19040777.
21. Streat SJ, Beddoe AH, Hill GL. Aggressive nutritional support does not prevent protein loss despite fat gain in septic intensive care patients. J Trauma 1987, 27:262-266. 10.1097/00005373-198703000-00006, 3104621.
22. Biolo G, De CM, Lorenzon S, Dal MV, Fantin D, Paroni R, Barazzoni R, Zanetti M, Iapichino G, Guarnieri G. Treating hyperglycemia improves skeletal muscle protein metabolism in cancer patients after major surgery. Crit Care Med 2008, 36:1768-1775. 10.1097/CCM.0b013e318174de32, 18496366.
23. Derde S, Vanhorebeek I, Ververs EJ, Vanhees I, Darras VM, Van HE, Larsson L, Van den Berghe G. Increasing intravenous glucose load in the presence of normoglycemia: effect on outcome and metabolism in critically ill rabbits. Crit Care Med 2010, 38:602-611. 10.1097/CCM.0b013e3181c03f65, 19851097.
24. Heyland DK, Dhaliwal R, Drover JW, Gramlich L, Dodek P. Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients. JPEN J Parenter Enteral Nutr 2003, 27:355-373. 10.1177/0148607103027005355, 12971736.
25. Martindale RG, Mcclave SA, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G. Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition: Executive Summary. Crit Care Med 2009, 37:1757-1761. 10.1097/CCM.0b013e3181a40116, 19373044.
26. Singer P, Berger MM, Van den Berghe G, Biolo G, Calder P, Forbes A, Griffiths R, Kreyman G, Leverve X, Pichard C, . ESPEN ESPEN Guidelines on Parenteral Nutrition: intensive care. Clin Nutr 2009, 28:387-400. 10.1016/j.clnu.2009.04.024, 19505748, ESPEN.
27. Preiser JC, Berre J, Carpentier Y, Jolliet P, Pichard C, Van GA, Vincent JL. Management of nutrition in European intensive care units: results of a questionnaire. Working Group on Metabolism and Nutrition of the European Society of Intensive Care Medicine. Intensive Care Med 1999, 25:95-101. 10.1007/s001340050793, 10051085.
28. Rhee P, Hadjizacharia P, Trankiem C, Chan L, Salim A, Brown C, Green D, Inaba K, Law J, Demetriades D. What happened to total parenteral nutrition? The disappearance of its use in a trauma intensive care unit. J Trauma 2007, 63:1215-1222. 10.1097/TA.0b013e31815b83e9, 18212641.
29. Kondrup J, Allison SP, Elia M, Vellas B, Plauth M. ESPEN guidelines for nutrition screening 2002. Clin Nutr 2003, 22:415-421. 10.1016/S0261-5614(03)00098-0, 12880610.
30. Van den Berghe G, Wilmer A, Milants I, Wouters PJ, Bouckaert B, Bruyninckx F, Bouillon R, Schetz M. Intensive insulin therapy in mixed medical/surgical intensive care units: benefit versus harm. Diabetes 2006, 55:3151-3159. 10.2337/db06-0855, 17065355.
31. Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest 1992, 101:1644-1655. 10.1378/chest.101.6.1644, 1303622.
32. Jolliet P, Pichard C, Biolo G, Chiolero R, Grimble G, Leverve X, Nitenberg G, Novak I, Planas M, Preiser JC, Roth E, Schols AM, Wernerman J. Enteral nutrition in intensive care patients: a practical approach. Working Group on Nutrition and Metabolism, ESICM. European Society of Intensive Care Medicine. Intensive Care Med 1998, 24:848-859. 10.1007/s001340050677, 9757932.
33. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999, 20:250-278. 10.1086/501620, 10219875.
34. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol 1992, 13:606-608. 10.1086/646436, 1334988.
35. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002, 166:111-117. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories.
36. Langouche L, Perre SV, Thiessen S, Gunst J, Hermans G, D'Hoore A, Kola B, Korbonits M, Van den Berghe G. Alterations in adipose tissue during critical illness: An adaptive and protective response?. Am J Respir Crit Care Med 2010, 182:507-516. 10.1164/rccm.200909-1395OC, 20442437.
37. Nasraway SA, Albert M, Donnelly AM, Ruthazer R, Shikora SA, Saltzman E. Morbid obesity is an independent determinant of death among surgical critically ill patients. Crit Care Med 2006, 34:964-970. 10.1097/01.CCM.0000205758.18891.70, 16484910.
38. O'Brien JM, Phillips GS, Ali NA, Lucarelli M, Marsh CB, Lemeshow S. Body mass index is independently associated with hospital mortality in mechanically ventilated adults with acute lung injury. Crit Care Med 2006, 34:738-744. 1868702, 16521268.