• Julia L M Bels, Steven Thiessen, Rob J J van Gassel, Albertus Beishuizen, Ashley De Bie Dekker, Vincent Fraipont, Stoffel Lamote, Didier Ledoux, Clarissa Scheeren, Elisabeth De Waele, van ZantenArthur R HARHDepartment of Intensive Care Medicine, Ziekenhuis Gelderse Vallei, Ede, Netherlands; Department of Human Nutrition and Health, Wageningen University and Research, Wageningen, Netherlands., Laura Bormans-Russell, Bas C T van Bussel, Marlies M J Dictus, Tom Fivez, Ingeborg Harks, van der HorstIwan C CICCDepartment of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, Netherlands; Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, Netherlands., Joop Jonckheer, Hugues Marechal, Paul B Massion, Ingrid Meex, Michelle C Paulus, Martin Rinket, Susanne van Santen, Katrien Tartaglia, Adam M Deane, Frieda Demuydt, Zudin Puthucheary, VloetLilian C MLCMFoundation Family and Patient Centered Intensive Care, IC Connect, Alkmaar, Netherlands; Research Department Emergency and Critical Care, School of Health Studies, Hogeschool van Arnhem en Nijmegen University of Applied Sciences, Nijmege, WeijsPeter J MPJMFaculty of Sports and Nutrition, Centre of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, Netherlands., van KuijkSander M JSMJDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, Netherlands., van de PollMarcel C GMCGDepartment of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, Netherlands; Department of Surgery, Maastricht University Medical Center, Maastricht, Netherlands; Maastricht School for Nutrition and Transla, Dieter Mesotten, and PRECISe study team.
• Department of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, Netherlands; Maastricht School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.
• Lancet. 2024 Aug 17; 404 (10453): 659669659-669.

BackgroundIncreased protein provision might ameliorate muscle wasting and improve long-term outcomes in critically ill patients. The aim of the PRECISe trial was to assess whether higher enteral protein provision (ie, 2·0 g/kg per day) would improve health-related quality of life and functional outcomes in critically ill patients who were mechanically ventilated compared with standard enteral protein provision (ie, 1·3 g/kg per day).MethodsThe PRECISe trial was an investigator-initiated, double-blinded, multicentre, parallel-group, randomised controlled trial in five Dutch hospitals and five Belgian hospitals. Inclusion criteria were initiation of invasive mechanical ventilation within 24 h of intensive care unit (ICU) admission and an expected duration of invasive ventilation of 3 days or longer. Exclusion criteria were contraindications for enteral nutrition, moribund condition, BMI less than 18 kg/m2, kidney failure with a no dialysis code, or hepatic encephalopathy. Patients were randomly assigned to one of four randomisation labels, corresponding with two study groups (ie, standard or high protein; two labels per group) in a 1:1:1:1 ratio through an interactive web-response system. Randomisation was done via random permuted-block randomisation in varying block sizes of eight and 12, stratified by centre. Participants, care providers, investigators, outcome assessors, data analysts, and the independent data safety monitoring board were all blinded to group allocation. Patients received isocaloric enteral feeds that contained 1·3 kcal/mL and 0·06 g of protein/mL (ie, standard protein) or 1·3 kcal/mL and 0·10 g of protein/mL (ie, high protein). The study-nutrition intervention was limited to the time period during the patient's ICU stay in which they required enteral feeding, with a maximum of 90 days. The primary outcome was EuroQoL 5-Dimension 5-level (EQ-5D-5L) health utility score at 30 days, 90 days, and 180 days after randomisation, adjusted for baseline EQ-5D-5L health utility score. This trial was registered with ClinicalTrials.gov (NCT04633421) and is closed to new participants.FindingsBetween Nov 19, 2020, and April 14, 2023, 935 patients were randomly assigned. 335 (35·8%) of 935 patients were female and 600 (64·2%) were male. 465 (49·7%) of 935 were assigned to the standard protein group and 470 (50·3%) were assigned to the high protein group. 430 (92·5%) of 465 patients in the standard protein group and 419 (89·1%) of 470 patients in the high protein group were assessed for the primary outcome. The primary outcome, EQ-5D-5L health utility score during 180 days after randomisation (assessed at 30 days, 90 days, and 180 days), was lower in patients allocated to the high protein group than in those allocated to the standard protein group, with a mean difference of -0·05 (95% CI -0·10 to -0·01; p=0·031). Regarding safety outcomes, the probability of mortality during the entire follow-up was 0·38 (SE 0·02) in the standard protein group and 0·42 (0·02) in the high protein group (hazard ratio 1·14, 95% CI 0·92 to 1·40; p=0·22). There was a higher incidence of symptoms of gastrointestinal intolerance in patients in the high protein group (odds ratio 1·76, 95% CI 1·06 to 2·92; p=0·030). Incidence of other adverse events did not differ between groups.InterpretationHigh enteral protein provision compared with standard enteral protein provision resulted in worse health-related quality of life in critically ill patients and did not improve functional outcomes during 180 days after ICU admission.FundingNetherlands Organisation for Healthcare Research and Development and Belgian Health Care Knowledge Centre.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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