Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

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

Authors: Michaël P Casaer, Greet Hermans, Alexander Wilmer, Greet Van den Berghe

Published in: Trials | Issue 1/2011

Login to get access

Abstract

Background

For critically ill patients treated in intensive care units (ICU), two feeding strategies are currently being advocated, one by American/Canadian and the other by European expert guidelines. These guidelines differ particularly in the timing of initiating parenteral nutrition (PN) in patients for whom enteral nutrition (EN) does not reach caloric targets.

Methods/Design

The EPaNIC trial is an investigator-initiated, non-commercial, multi-center, randomized, controlled, clinical trial with a parallel group design. This study compares early (European guideline) versus late (American/Canadian guideline) initiation of PN when EN fails to reach a caloric target. In the early PN group, PN is initiated within 24-48 hours after ICU admission to complete early enteral nutrition (EN) up to a calculated nutritional target. In the late PN group, PN completing EN is initiated when the target is not reached on day 8. In both groups, the same early EN protocol is applied. The study is designed to compare clinical outcome (morbidity and mortality) in the 2 study arms as well as to address several mechanistical questions. We here describe the EPaNIC study protocol and the statistical analysis plan for the primary report of the clinical results.

Discussion

The study has been initiated as planned on august 01 2007. One interim analysis advised continuation of the trial. The study will be completed in February 2011.

Trial Registration

ClinicalTrials (NCT): NCT00512122
Appendix
Available only for authorised users
Literature
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.CrossRefPubMed
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.PubMedPubMedCentral
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.CrossRefPubMed
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.PubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMedPubMedCentral
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.CrossRefPubMed
19.
Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van dH, 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.CrossRefPubMed
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.CrossRefPubMedPubMedCentral
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRef
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMedPubMedCentral
Metadata
Title
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
Authors
Michaël P Casaer
Greet Hermans
Alexander Wilmer
Greet Van den Berghe
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-21

Other articles of this Issue 1/2011

Trials 1/2011 Go to the issue

Research

Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial

Study protocol

Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol

Study protocol

Mums 4 Mums: structured telephone peer-support for women experiencing postnatal depression. Pilot and exploratory RCT of its clinical and cost effectiveness

Study protocol

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

Study protocol

The utility of Aspirin in dukes C and high risk dukes B colorectal cancer - The ASCOLT study: study protocol for a randomized controlled trial

Study protocol

Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial