The impact of high versus standard enteral protein provision on functional recovery following intensive care admission (PRECISE trial): study protocol for a randomized controlled, quadruple blinded, multicenter, parallel group trial in mechanically ventilated patients.
van Gassel, Rob J J; Bels, Julia L M; Tartaglia, Katrienet al.
Critical illness; Dietary protein; Enteral nutrition; Functional outcomes; Nutrition therapy; Humans; Critical Care/methods; Time; Recovery of Function; Intensive Care Units; Critical Illness; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; Quality of Life; Respiration, Artificial/adverse effects; Critical Care; Respiration, Artificial; Medicine (miscellaneous); Pharmacology (medical)
Abstract :
[en] [en] BACKGROUND: Critically ill patients are subject to severe skeletal muscle wasting during intensive care unit (ICU) stay, resulting in impaired short- and long-term functional outcomes and health-related quality of life. Increased protein provision may improve functional outcomes in ICU patients by attenuating skeletal muscle breakdown. Supporting evidence is limited however and results in great variety in recommended protein targets.
METHODS: The PRECISe trial is an investigator-initiated, bi-national, multi-center, quadruple-blinded randomized controlled trial with a parallel group design. In 935 patients, we will compare provision of isocaloric enteral nutrition with either a standard or high protein content, providing 1.3 or 2.0 g of protein/kg/day, respectively, when fed on target. All unplanned ICU admissions with initiation of invasive mechanical ventilation within 24 h of admission and an expected stay on ventilator support of at least 3 days are eligible. The study is designed to assess the effect of the intervention on functional recovery at 1, 3, and 6 months following ICU admission, including health-related quality of life, measures of muscle strength, physical function, and mental health. The primary endpoint of the trial is health-related quality of life as measured by the Euro-QoL-5D-5-level questionnaire Health Utility Score. Overall between-group differences will be assessed over the three time points using linear mixed-effects models.
DISCUSSION: The PRECISe trial will evaluate the effect of protein on functional recovery including both patient-centered and muscle-related outcomes.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04633421 . Registered on November 18, 2020. First patient in (FPI) on November 19, 2020. Expected last patient last visit (LPLV) in October 2023.
Disciplines :
Anesthesia & intensive care
Author, co-author :
van Gassel, Rob J J; Department of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, the Netherlands ; NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands ; Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
Bels, Julia L M ; Department of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, the Netherlands. julia.bels@mumc.nl ; NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands. julia.bels@mumc.nl
Tartaglia, Katrien; Clinical Trial Unit, Ziekenhuis Oost-Limburg, Genk, Belgium
van Bussel, Bas C T; Department of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, the Netherlands ; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands
van Kuijk, Sander M J; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands
Deane, Adam M; Department of Critical Care, Melbourne Medical School, University of Melbourne, Parkville, Australia
Puthucheary, Zudin; William Harvey Research Institute, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, London, UK ; Adult Critical Care Unit, Royal London Hospital, London, UK
Weijs, Peter J M; Department of Nutrition and Dietetics, Faculty of Sports and Nutrition, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands ; Department of Nutrition and Dietetics, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands
Vloet, Lilian; Research Department of Emergency and Critical Care, HAN University of Applied Science, School of Health Studies, Nijmegen, the Netherlands ; IQ Healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands
Beishuizen, Bert; Department of Intensive Care Medicine, Medisch Spectrum Twente, Enschede, the Netherlands
De Bie Dekker, Ashley; Department of Intensive Care, Catharina Hospital, Eindhoven, the Netherlands
Fraipont, Vincent; Service of Intensive Care Medicine, Citadelle Hospital, Liège, Belgium
Lamote, Stoffel; Department of Intensive Care Medicine, AZ Groeninge, Kortrijk, Belgium
Ledoux, Didier ; Centre Hospitalier Universitaire de Liège - CHU > > Service des soins intensifs
Scheeren, Clarissa; Department of Intensive Care Medicine, Zuyderland Medisch Centrum, Heerlen/Sittard, the Netherlands
De Waele, Elisabeth; Departement of Nutrition, Universitair Ziekenhuis Brussel, Jette, Belgium
van Zanten, Arthur R H; Department of Intensive Care, Gelderse Vallei Hospital, Ede, the Netherlands
Mesotten, Dieter; Department of Intensive Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium ; Faculty of Medicine and Life Sciences, UHasselt, Diepenbeek, Belgium
van de Poll, Marcel C G; Department of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, the Netherlands ; NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands ; Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
The impact of high versus standard enteral protein provision on functional recovery following intensive care admission (PRECISE trial): study protocol for a randomized controlled, quadruple blinded, multicenter, parallel group trial in mechanically ventilated patients.
KCE - Belgian Health Care Knowledge Centre ZonMw - Nederlandse Organisatie voor Gezondheidsonderzoek en Zorginnovatie
Funding text :
The PRECISe team would like to acknowledge our funders ZonMW and KCE, whose collaboration within the BeNeFIT program made it possible to perform the PRECISe trial, as well as Nutricia Research, who provided the study nutrition free of charge. Furthermore, we want to thank our patient representatives, who gave important input to the set-up and execution of the trial, ensuring the patient’s perspective throughout. Importantly, we acknowledge all involved patients and their relatives, without whom it would not be possible to perform the trial and answer these important research questions. Lastly, we thank all nurses at the study sites, who care for the PRECISe participants and make it possible to perform the intervention and collect the needed data. The PRECISe study team consists of Prof. Arthur van Zanten, Dr. Bert Beishuizen, Prof. Elisabeth de Waele, Dr. Vincent Fraipont, Dr. Zudin Puthucheary, Prof. Adam Deane, Prof. Peter Weijs, Dr. Lilian Vloet, Ms. Frieda Demuydt, and Dr. Susanne van Santen. The full list of members of participating sites, principal investigators, co-investigators, and study coordinators can be found in the supplemental documents.Funding for this trial was provided under the BeNeFIT program of the Netherlands Organisation for Health Research and Development (ZonMW) and the Belgian Health Care Knowledge Center (KCE). Blinded enteral nutrition for the trial was provided in kind by Nutricia Research, Utrecht, the Netherlands. All funders had no role in the design of the study nor in the collection, analysis, and interpretation of data, and in writing the manuscript.
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