Impact of early parenteral nutrition completing enteral nutrition in adult critically ill patients

INTERVENTION: Trade Name: Oliclinomel N7‐1000 E, emulsion for infusion Pharmaceutical Form: Emulsion for infusion Trade Name: Oliclinomel N7‐1000 Pharmaceutical Form: Emulsion for infusion Trade Name: Clinimix N14G30E Pharmaceutical Form: Emulsion for infusion Trade Name: Clinimix N17G35E Pharmaceutical Form: Emulsion for infusion Trade Name: Clinimix N17G35 Pharmaceutical Form: Emulsion for infusion CONDITION: Critical Illness ; MedDRA version: 9.1 Level: LLT Classification code 10063889 Term: Oral intake reduced ; MedDRA version: 9.1 Level: LLT Classification code 10041954 Term: Starvation PRIMARY OUTCOME: Main Objective: To test the hypothesis that in critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of EN and PN (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN Primary end point(s): The primary outcome measure of this study will be length of stay in ICU and the hospital. Secondary Objective: To define which underlying mechanisms may explain the eventual benefits of combined enteral and parenteral nutrition during critical illness; ‐by studying the effects of “EN combined with early PN” vs “EN” on nitrogen balance, muscle strength, and rehabilitation (as assessed by Medical Research Council (MRC) Sum Score testing, hand held dynamometry [Jamar©], isometric force [microfet©]) and Maximal Inspiratory Pressure (MIP), 6 minutes walking distance, muscle ultrasonography and quantitative computer tomography, rehabilitation……); ‐by studying the effects of “EN combined with early PN” vs “EN” on cellular, biochemical and metabolic processes in skeletal muscle and adipose tissue at a fixed time point during illness and in skeletal muscle, liver and adipose tissue sampled immediately post mortem.; 2.3. by studying the effects of “EN combined with early PN” vs “EN” on the “innate immune response” and pathways of inflammation INCLUSION CRITERIA: Patients older than 18 years admitted to any of the 6 intensive care units will be eligible for inclusion in the study, on condition that the nutritional risk screening (NRS)score is higher or equal to 3. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range