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Cited by 174Clinical Nutrition and GastroenterologyIntensive Care Unit Cognitive DisordersNutrition and Health in Aging

Effect of high versus standard protein provision on functional recovery in people with critical illness (PRECISe): an investigator-initiated, double-blinded, multicentre, parallel-group, randomised controlled trial in Belgium and the Netherlands

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Bels, Julia L M, Thiessen, Steven, van Gassel, Rob J J, Beishuizen, Albertus, De Bie Dekker, Ashley, Fraipont, Vincent, Lamote, Stoffel, Ledoux, Didier +83 more·2024·The Lancet
DOI 10.1016/s0140-6736(24)01304-7
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Abstract

Background Increased protein provision might ameliorate muscle wasting and improve long-term outcomes in critically ill patients. The aim of the PRECISe trial was to assess whether higher enteral protein provision (ie, 2·0 g/kg per day) would improve health-related quality of life and functional outcomes in critically ill patients who were mechanically ventilated compared with standard enteral protein provision (ie, 1·3 g/kg per day). Methods The PRECISe trial was an investigator-initiated, double-blinded, multicentre, parallel-group, randomised controlled trial in five Dutch hospitals and five Belgian hospitals. Inclusion criteria were initiation of invasive mechanical ventilation within 24 h of intensive care unit (ICU) admission and an expected duration of invasive ventilation of 3 days or longer. Exclusion criteria were contraindications for enteral nutrition, moribund condition, BMI less than 18 kg/m 2, kidney failure with a no dialysis code, or hepatic encephalopathy. Patients were randomly assigned to one of four randomisation labels, corresponding with two study groups (ie, standard or high protein; two labels per group) in a 1:1:1:1 ratio through an interactive web-response system. Randomisation was done via random permuted-block randomisation in varying block sizes of eight and 12, stratified by centre. Participants, care providers, investigators, outcome assessors, data analysts, and the independent data safety monitoring board were all blinded to group allocation. Patients received isocaloric enteral feeds that contained 1·3 kcal/mL and 0·06 g of protein/mL (ie, standard protein) or 1·3 kcal/mL and 0·10 g of protein/mL (ie, high protein). The study-nutrition intervention was limited to the time period during the patient's ICU stay in which they required enteral feeding, with a maximum of 90 days. The primary outcome was EuroQoL 5-Dimension 5-level (EQ-5D-5L) health utility score at 30 days, 90 days, and 180 days after randomisation, adjusted for baseline EQ-5D-5L health utility score. This trial was registered with ClinicalTrials.gov (NCT04633421) and is closed to new participants. Findings Between Nov 19, 2020, and April 14, 2023, 935 patients were randomly assigned. 335 (35·8%) of 935 patients were female and 600 (64·2%) were male. 465 (49·7%) of 935 were assigned to the standard protein group and 470 (50·3%) were assigned to the high protein group. 430 (92·5%) of 465 patients in the standard protein group and 419 (89·1%) of 470 patients in the high protein group were assessed for the primary outcome. The primary outcome, EQ-5D-5L health utility score during 180 days after randomisation (assessed at 30 days, 90 days, and 180 days), was lower in patients allocated to the high protein group than in those allocated to the standard protein group, with a mean difference of -0·05 (95% CI -0·10 to -0·01; p=0·031). Regarding safety outcomes, the probability of mortality during the entire follow-up was 0·38 (SE 0·02) in the standard protein group and 0·42 (0·02) in the high protein group (hazard ratio 1·14, 95% CI 0·92 to 1·40; p=0·22). There was a higher incidence of symptoms of gastrointestinal intolerance in patients in the high protein group (odds ratio 1·76, 95% CI 1·06 to 2·92; p=0·030). Incidence of other adverse events did not differ between groups. Interpretation High enteral protein provision compared with standard enteral protein provision resulted in worse health-related quality of life in critically ill patients and did not improve functional outcomes during 180 days after ICU admission. Funding Netherlands Organisation for Healthcare Research and Development and Belgian Health Care Knowledge Centre.

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Authors
Bels, J. L. M., Thiessen, S., van Gassel, R. J. J., Beishuizen, A., De Bie Dekker, A., Fraipont, V., Lamote, S., Ledoux, D., Scheeren, C., De Waele, E., van Zanten, A. R. H., Bormans-Russell, L., van Bussel, B. C. T., Dictus, M. M. J., Fivez, T., Harks, I., van der Horst, I. C. C., Jonckheer, J., Marechal, H., Massion, P. B., Meex, I., Paulus, M. C., Rinket, M., van Santen, S., Tartaglia, K., Deane, A. M., Demuydt, F., Puthucheary, Z., Vloet, L. C. M., Weijs, P. J. M., van Kuijk, S. M. J., van de Poll, M. C. G., Mesotten, D., Bels, J. L., van Bussel, B. C., van Gassel, R. J., van der Horst, I. C., van Kuijk, S. M., van de Poll, M. C., van Santen, S., van den Berk, D., van den Hogen, E., van Loon, L.-A., van Loon, L. J., Dictus, M. M., Fiez, T., Meex, I., Mesotten, D., Tartaglia, K., Thiessen, S., Boer, W., Engelen, K., Vander Laenen, M., Willaert, X., Jonckheer, J., De Waele, E., Demol, J., Geers, J., van Malderen, M.-C., Opdenacker, G., Verhelst, C., Paulus, M. C., van Zanten, A. R., Bouw-Ruiter, M., Kouw, I., Melchers, M., Osinga, M., Swaen-Dekkers, Y., De Bie Dekker, A., Harks, I., Beishuizen, A., Rinket, M., Cornet, A. D., Krol, T., Vermeijden, W., Bormans-Russell, L., Scheeren, C., van der Woude, M., Zandijk, E., Lamote, S., Lagast, S., Boscart, I., Ledoux, D., Massion, P., Fraipont, V., Marechal, H., Demuydt, F., Vloet, L., Weijs, P. M., Puthucheary, Z., & Deane, A.
Affiliations
  • Ziekenhuis Oost-Limburg (BE)
  • Centre Hospitalier Universitaire de Liège (BE)
  • HAN University of Applied Sciences (NL)
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2024-08
Volume
404
Issue
10453
Pages
659-669
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(24)01304-7
OpenAlex
W4401598369
Cited by
174
References
34
Citations by year
2026: 90 · 2025: 69 · 2024: 15
FWCI
46.49
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • TU/e Research Portal (publishedVersion)
  • Socio-Environmental Systems Modeling (submittedVersion)
  • ORBi (University of Liège) (submittedVersion, other-oa)
  • Pure Amsterdam UMC (submittedVersion, other-oa)
  • Research Publications (Maastricht University) (submittedVersion, other-oa)
  • Research Publications (Maastricht University) (submittedVersion)
  • Document Server@UHasselt (UHasselt) (submittedVersion)
  • Radboud Repository (Radboud University) (submittedVersion)
  • VUBIR (Vrije Universiteit Brussel) (submittedVersion)
Funders
  • Nutricia Research BV
  • KCE
  • NWO
Topics
  • Health Sciences › Nursing › Nutrition and Dietetics › Clinical Nutrition and Gastroenterology
  • Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Intensive Care Unit Cognitive Disorders
  • Health Sciences › Medicine › Physiology › Nutrition and Health in Aging
Keywords
critically ill patients, mechanical ventilation, functional recovery, health-related quality of life, muscle atrophy, ICU nutrition, catabolic phase, PRECISE trial, hepatic encephalopathy
MeSH terms
Aged, Belgium, Dietary Proteins, Double-Blind Method, Enteral Nutrition, Female, Humans, Intensive Care Units, Male, Middle Aged, Netherlands, Quality of Life, Respiration, Artificial, Critical Illness, Recovery of Function

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