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document
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/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 .
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Intervention_Physical
initiation of PN when EN fails
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Intervention_Physical
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
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Intervention_Physical
In the late PN group , PN completing EN is initiated when the target is not reached on day 8
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Intervention_Physical
EN
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Outcome_Mortality
morbidity and mortality
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Participant_Condition
adult critically ill patients
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Participant_Condition
critically ill patients treated in intensive care units ( ICU
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Participant_Condition
patients for whom enteral nutrition ( EN ) does not reach caloric targets