The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: A pre-planned Bayesian analysis of the PRECISe trial. - 2025
The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: A pre-planned Bayesian analysis of the PRECISe trial.
Schouteden, Eline; Heuts, Samuel; Bels, Julia Lmet al.
Bayesian; Critical illness; High protein provision; Nutrition; Quality of life; Standard protein provision; Dietary Proteins; Aged; Female; Humans; Male; Middle Aged; Bayes Theorem; Intensive Care Units; Quality of Life; Treatment Outcome; Critical Care/methods; Critical Illness/therapy; Critical Illness/mortality; Dietary Proteins/administration & dosage; Enteral Nutrition/methods; Recovery of Function; Critical Care; Enteral Nutrition; Nutrition and Dietetics; Critical Care and Intensive Care Medicine
Abstract :
[en] [en] BACKGROUND AND AIMS: High protein nutrition may improve outcomes after critical illness. We recently published the primary frequentist analysis of the PRECISe trial, showing that high (2.0 g/kg/day) compared with standard (1.3 g/kg/day) protein provision led to statistically significant worse health-related quality of life. The study, however, was not powered to draw definitive conclusions about clinical and other functional outcomes under a frequentist framework. We present a pre-planned and pre-specified Bayesian analysis to facilitate the clinical interpretation of these paramount endpoints.
METHODS: The trial enrolled 935 patients and used the EQ-5D-5L health utility score as the primary endpoint. We performed Bayesian analyses of the primary and selected secondary endpoints, and relevant subgroups, under weakly informative priors. Sensitivity analyses were performed using skeptical and enthusiastic priors, and informed priors (when available) based on existing literature. Thresholds for clinically relevant differences were predefined.
RESULTS: The posterior probability of benefit from high (2.0 g/kg/day) protein targets with respect to the EQ-5D-5L health utility score was 0 %. Concerning 60-day mortality, the posterior probability of any benefit from high protein provision was 8 %, with a posterior probability of clinically important harm (>5 % absolute risk difference) of 47 %, which varied between 1 and 21 % across various sensitivity analyses under reference or literature-based priors.
CONCLUSIONS: This pre-planned Bayesian re-analysis of the PRECISe trial shows that high (2.0 g/kg/day) compared to standard (1.3 g/kg/day) protein provision in critically ill patients has a low probability to yield any benefit and results in a high probability of an increase of 60-day mortality.
REGISTRATION NUMBER OF CLINICAL TRIAL: NCT04633421.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Schouteden, Eline; Department of Intensive Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium, Faculty of Medicine and Life Sciences, UHasselt, Diepenbeek, Belgium
Heuts, Samuel; Department of Cardiothoracic Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands
Bels, Julia Lm; Department of Intensive Care Medicine, Maastricht University Medical Center+, Maastricht, the Netherlands, School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands
Thiesen, Steven; Department of Intensive Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium, Faculty of Medicine and Life Sciences, UHasselt, Diepenbeek, Belgium, Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium
van Gassel, Rob Jj; Department of Intensive Care Medicine, Maastricht University Medical Center+, Maastricht, the Netherlands, School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands, Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands
Lee, Zheng-Yii; Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia
Stoppe, Christian; Department of Cardiac Anesthesiology & Intensive Care Medicine, Charité Berlin, Germany, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany
Beishuizen, Albertus; Intensive Care Center, Medisch Spectrum Twente, Enschede, the Netherlands
De Bie Dekker, Ashley; Department of Intensive Care Medicine, Catharina Ziekenhuis Eindhoven, Eindhoven, the Netherlands
Fraipont, Vincent; Intensive Care Unit, Citadelle Hospital, Liège, Belgium
Lamote, Stoffel; Department of Intensive Care Medicine, Academisch Ziekenhuis Groeninge, Kortijk, Belgium
Ledoux, Didier ; Centre Hospitalier Universitaire de Liège - CHU > > Service des soins intensifs
Scheeren, Clarissa; Department of Intensive Care Medicine, Zuyderland Medisch Centrum, Heerlen, the Netherlands
De Waele, Elisabeth; Department of Nutrition, Universitair Ziekenhuis Brussel, Jette, Belgium
van Zanten, Arthur; Department of Intensive Care Medicine, Gelderse Vallei Ziekenhuis, Ede, the Netherlands, Division of Human Nutrition & Health, Wageningen University & Research, Wageningen, the Netherlands
van Kuijk, Sander Mj; Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht University Medical Center+, Maastricht, the Netherlands
van de Poll, Marcel Cg; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands, Department of Intensive Care Medicine, Maastricht University Medical Center+, Maastricht, the Netherlands, Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands. Electronic address: marcel.vande.poll@mumc.nl
Mesotten, Dieter; Department of Intensive Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium, Faculty of Medicine and Life Sciences, UHasselt, Diepenbeek, Belgium, Clinical Trial Unit (Future Health), Ziekenhuis Oost-Limburg, Genk, Belgium
Gabrio, Andrea; Department of Methodology and Statistics, Maastricht University, Maastricht, the Netherlands
The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: A pre-planned Bayesian analysis of the PRECISe trial.
ZonMw - Netherlands Organisation for Health Research and Development Danone Nutricia Research KCE - Belgian Health Care Knowledge Centre
Funding text :
This report is independent research funded by the Netherlands Organisation for Healthcare Research and Development (ZonMw) and the Belgian Health Care Knowledge Centre (KCE) ([BENEFIT], The impact of high versus standard protein provision on functional recovery following Intensive Care admission: a randomised controlled, multicentre, parallel-group trial in mechanically ventilated, critically ill patients [Reference number 80-85200-98-18574]). The views expressed in this publication are those of the author(s) and not necessarily those of ZonMw or the Belgian Health Care Knowledge Centre, or the Department of Health. Blinded study feeds were provided in kind by Nutricia Research.
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