Abstract
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.
| Original language | English |
|---|---|
| Article number | 416 |
| Number of pages | 18 |
| Journal | Trials |
| Volume | 24 |
| DOIs | |
| Publication status | Published - 2023 |
Funding
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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