Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jun 19;24(1):416.
doi: 10.1186/s13063-023-07380-3.

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  1   2   3 , Julia L M Bels  4   5 , Katrien Tartaglia  6 , Bas C T van Bussel  1   7 , Sander M J van Kuijk  8 , Adam M Deane  9 , Zudin Puthucheary  10   11 , Peter J M Weijs  12   13 , Lilian Vloet  14   15 , Bert Beishuizen  16 , Ashley De Bie Dekker  17 , Vincent Fraipont  18 , Stoffel Lamote  19 , Didier Ledoux  20   21 , Clarissa Scheeren  22 , Elisabeth De Waele  23 , Arthur R H van Zanten  24 , Dieter Mesotten #  25   26 , Marcel C G van de Poll #  1   2   3
Affiliations

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 et al. Trials. .

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.

Keywords: Critical illness; Dietary protein; Enteral nutrition; Functional outcomes; Nutrition therapy.

PubMed Disclaimer

Conflict of interest statement

Model consent forms for study participation for patient and for patient’s proxy, both in Dutch and in French, will be made available on request.

Competing interests {28}

ZP has received honoraria for consultancy from Nestle, Nutricia, Faraday Pharmaceuticals, and Fresenius-Kabi and speaker fees from Baxter, Fresenius-Kabi, Nutricia, and Nestle. No other potential competing interest was reported by the authors.

Figures

Fig. 1
Fig. 1
CONSORT diagram of participants in the PRECISe trial (CONSORT diagram)
See this image and copyright information in PMC

References

    1. Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, et al. Acute skeletal muscle wasting in critical illness. JAMA. 2013;310(15):1591–1600. doi: 10.1001/jama.2013.278481. - DOI - PubMed
    1. Herridge MS, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, et al. The RECOVER program: disability risk groups and 1-year outcome after 7 or more days of mechanical ventilation. Am J Respir Crit Care Med. 2016;194(7):831–844. doi: 10.1164/rccm.201512-2343OC. - DOI - PubMed
    1. Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, et al. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness. A cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014;190(4):410–20. doi: 10.1164/rccm.201312-2257OC. - DOI - PubMed
    1. Herridge MS, Tansey CM, Matté A, Tomlinson G, Diaz-Granados N, Cooper A, et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011;364(14):1293–1304. doi: 10.1056/NEJMoa1011802. - DOI - PubMed
    1. van Gassel RJJ, Baggerman MR, van de Poll MCG. Metabolic aspects of muscle wasting during critical illness. Curr Opin Clin Nutr Metab Care. 2020;23(2):96–101. doi: 10.1097/MCO.0000000000000628. - DOI - PMC - PubMed

Publication types

Associated data