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Randomized Controlled Trial
. 2025 May:48:153-160.
doi: 10.1016/j.clnu.2025.03.022. Epub 2025 Apr 1.

The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: A pre-planned Bayesian analysis of the PRECISe trial

Eline Schouteden  1 , Samuel Heuts  2 , Julia Lm Bels  3 , Steven Thiesen  4 , Rob Jj van Gassel  5 , Zheng-Yii Lee  6 , Christian Stoppe  7 , Albertus Beishuizen  8 , Ashley De Bie Dekker  9 , Vincent Fraipont  10 , Stoffel Lamote  11 , Didier Ledoux  12 , Clarissa Scheeren  13 , Elisabeth De Waele  14 , Arthur van Zanten  15 , Sander Mj van Kuijk  16 , Marcel Cg van de Poll  17 , Dieter Mesotten  18 , Andrea Gabrio  19 ; PRECISe study team
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Free article
Randomized Controlled Trial

The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: A pre-planned Bayesian analysis of the PRECISe trial

Eline Schouteden et al. Clin Nutr. 2025 May.
Free article

Abstract

Background and aims: High protein nutrition may improve outcomes after critical illness. We recently published the primary frequentist analysis of the PRECISe trial, showing that high (2.0 g/kg/day) compared with standard (1.3 g/kg/day) protein provision led to statistically significant worse health-related quality of life. The study, however, was not powered to draw definitive conclusions about clinical and other functional outcomes under a frequentist framework. We present a pre-planned and pre-specified Bayesian analysis to facilitate the clinical interpretation of these paramount endpoints.

Methods: The trial enrolled 935 patients and used the EQ-5D-5L health utility score as the primary endpoint. We performed Bayesian analyses of the primary and selected secondary endpoints, and relevant subgroups, under weakly informative priors. Sensitivity analyses were performed using skeptical and enthusiastic priors, and informed priors (when available) based on existing literature. Thresholds for clinically relevant differences were predefined.

Results: The posterior probability of benefit from high (2.0 g/kg/day) protein targets with respect to the EQ-5D-5L health utility score was 0 %. Concerning 60-day mortality, the posterior probability of any benefit from high protein provision was 8 %, with a posterior probability of clinically important harm (>5 % absolute risk difference) of 47 %, which varied between 1 and 21 % across various sensitivity analyses under reference or literature-based priors.

Conclusions: This pre-planned Bayesian re-analysis of the PRECISe trial shows that high (2.0 g/kg/day) compared to standard (1.3 g/kg/day) protein provision in critically ill patients has a low probability to yield any benefit and results in a high probability of an increase of 60-day mortality.

Registration number of clinical trial: NCT04633421.

Keywords: Bayesian; Critical illness; High protein provision; Nutrition; Quality of life; Standard protein provision.

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Conflict of interest statement

Conflict of interest EDW reports honoraria for scientific lectures from Baxter Healthcare, Nutricia/Danone, and Nestlé. AVZ reports grants from AOP Pharma, Danone/Nutricia, Fresenius-Kabi, PAION and Rousselot; Consulting fees from AOP Pharma, Medcaptain, and PAION; Honoraria for lectures from Abbott, AOP Pharma, Baxter, Nestlé, Danone/Nutricia, Fresenius Kabi, GE Healthcare and Dutch Medical Food; Support for travel from Danone/Nutricia and Dutch Medical Food; and membership of the ESPEN adult ICU patient nutrition guideline committee, Executive Team SepsisNet Netherlands, Executive Team NESPEN, and the ESICM Section Feeding, Rehabilitation Endocrinology and Metabolism (FREM) as chair. MVDP reports grants from the Netherlands Organisation of Health Research and Development (ZonMW) and the Belgian Knowledge Centre for Healthcare (KCE), in-kind support from Nutricia; Consulting fees from Nutricia and Nestlé, and honoraria for lectures and support for travel from Nutricia. All other authors (ES, SH, ST, JB, RVG, AB, ADBD, VF, SL, DL, CS, SVK, DM, AG) declare no competing interests.

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