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
Rob J. J. van Gassel,
Julia L. M. Bels,
Katrien Tartaglia,
Bas C. T. van Bussel,
Sander M. J. van Kuijk,
Adam M. Deane,
Zudin Puthucheary,
Peter J. M. Weijs,
Lilian Vloet,
Bert Beishuizen,
Ashley De Bie Dekker,
Vincent Fraipont,
Stoffel Lamote,
Didier Ledoux,
Clarissa Scheeren,
Elisabeth De Waele,
Arthur R. H. van Zanten,
Dieter Mesotten,
Marcel C. G. van de Poll
Affiliations
Rob J. J. van Gassel
Department of Intensive Care Medicine, Maastricht University Medical Center
Julia L. M. Bels
Department of Intensive Care Medicine, Maastricht University Medical Center
Katrien Tartaglia
Clinical Trial Unit, Ziekenhuis Oost-Limburg
Bas C. T. van Bussel
Department of Intensive Care Medicine, Maastricht University Medical Center
Sander M. J. van Kuijk
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center
Adam M. Deane
Department of Critical Care, Melbourne Medical School, University of Melbourne
Zudin Puthucheary
William Harvey Research Institute, Barts and The London School of Medicine & Dentistry, Queen Mary University of London
Peter J. M. Weijs
Department of Nutrition and Dietetics, Faculty of Sports and Nutrition, Amsterdam University of Applied Sciences
Lilian Vloet
Research Department of Emergency and Critical Care, HAN University of Applied Science, School of Health Studies
Bert Beishuizen
Department of Intensive Care Medicine, Medisch Spectrum Twente
Ashley De Bie Dekker
Department of Intensive Care, Catharina Hospital
Vincent Fraipont
Service of Intensive Care Medicine, Citadelle Hospital
Stoffel Lamote
Department of Intensive Care Medicine, AZ Groeninge
Didier Ledoux
Sensation & Perception Research Group, GIGA Consciousness, University of Liège
Clarissa Scheeren
Department of Intensive Care Medicine, Zuyderland Medisch Centrum
Elisabeth De Waele
Departement of Nutrition, Universitair Ziekenhuis Brussel
Arthur R. H. van Zanten
Department of Intensive Care, Gelderse Vallei Hospital
Dieter Mesotten
Department of Intensive Care Medicine, Ziekenhuis Oost-Limburg
Marcel C. G. van de Poll
Department of Intensive Care Medicine, Maastricht University Medical Center
Abstract 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.
