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.
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
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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials (NCT): NCT00512122.
Department of Intensive Care Medicine, University Hospitals Leuven, Katholieke Universiteit Leuven, Belgium. michael.casaer@uzleuven.be
Michaël P
MP
Casaer
Greet
G
Hermans
Alexander
A
Wilmer
Greet
G
Van den Berghe
D000328:Adult; D001530:Belgium; D003422:Critical Care; D016638:Critical Illness; D002149:Energy Intake; D004750:Enteral Nutrition; D006801:Humans; D007362:Intensive Care Units; D010288:Parenteral Nutrition; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
J Trauma. 1987 Mar;27(3):262-6
3104621
Am J Clin Nutr. 2001 Oct;74(4):534-42
11566654
Crit Care. 2007;11(1):R10
17254321
JAMA. 2008 Dec 17;300(23):2731-41
19088351
JPEN J Parenter Enteral Nutr. 1998 Nov-Dec;22(6):375-81
9829611
Chest. 2004 Apr;125(4):1446-57
15078758
Crit Care Med. 2006 Apr;34(4):964-70; quiz 971
16484910
J Trauma. 2007 Dec;63(6):1215-22
18212641
Chest. 1992 Jun;101(6):1644-55
1303622
CMAJ. 2004 Jan 20;170(2):197-204
14734433
Intensive Care Med. 1998 Aug;24(8):848-59
9757932
Intensive Care Med. 2004 Aug;30(8):1666-71
15185069
J Hum Nutr Diet. 2006 Feb;19(1):13-22
16448470
Diabetes. 2006 Nov;55(11):3151-9
17065355
Crit Care Med. 2004 Feb;32(2):350-7
14758147
Clin Nutr. 2009 Aug;28(4):387-400
19505748
Intensive Care Med. 1999 Jan;25(1):95-101
10051085
JPEN J Parenter Enteral Nutr. 2003 Jan-Feb;27(1):74-83
12549603
N Engl J Med. 2001 Nov 8;345(19):1359-67
11794168
Crit Care Med. 2010 Feb;38(2):602-11
19851097
Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7
12091180
Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80
10219875
Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8
1334988
Intensive Care Med. 2005 Jan;31(1):12-23
15592814
N Engl J Med. 2009 Mar 26;360(13):1283-97
19318384
JPEN J Parenter Enteral Nutr. 2003 Sep-Oct;27(5):355-73
12971736
Clin Nutr. 2005 Aug;24(4):502-9
15899538
Crit Care. 2008;12(6):238
19040777
Lancet. 2009 Feb 14;373(9663):547-56
19176240
Clin Nutr. 2006 Feb;25(1):37-44
16321459
Crit Care Med. 2008 Jun;36(6):1768-75
18496366
Crit Care Med. 2006 Mar;34(3):738-44
16521268
Am J Respir Crit Care Med. 2010 Aug 15;182(4):507-16
20442437
Crit Care Med. 2005 Jan;33(1):213-20; discussion 260-1
15644672
Clin Nutr. 2003 Aug;22(4):415-21
12880610
Crit Care Med. 2009 May;37(5):1757-61
19373044
Intensive Care Med. 2008 Jun;34(6):1054-9
18210092