Enteral citrulline supplementation versus placebo on SOFA score on day 7 in mechanically ventilated critically ill patients: the IMMUNOCITRE randomized clinical trial.

"Declarations Ethical approval and consent to participateThe research was conducted in accordance with the 1964 Helsinki Declaration. The study protocol was approved by the ethics committee from Brest, France (Comité de Protection des Personnes Ouest IV #2016–895) and by regulatory authorities (reference: 150806B-42). Signed informed consent was obtained from all the participants or their legally authorized representatives prior to enrollment and randomization. Competing interestsJean-Marc Tadié received personal fees from Biomerieux; Nicolas Terzi received personal fees from Pfizer; Jean-Luc Diehl reports research supports, grants and personal fees from ALung Technologies, Xenios, Fresenius Medical Care and Baxter, RonanThibault reports Royalties for designing the Simple Evaluation of Food Intake® (SEFI®) (Knoë, le Kremlin Bicêtre, France), consulting fees from Nestlé Health Science, Servier, Baxter, BBraun, Fresenius-Kabi, Nutricia, LeCancer and Nutricia, NHC, Novonordisk; Luc Cynober is a shareholder of Citrage Co, member of the Citrage Co Scientific Committee. Competing interests Jean-Marc Tadié received personal fees from Biomerieux; Nicolas Terzi received personal fees from Pfizer; Jean-Luc Diehl reports research supports, grants and personal fees from ALung Technologies, Xenios, Fresenius Medical Care and Baxter, RonanThibault reports Royalties for designing the Simple Evaluation of Food Intake® (SEFI®) (Knoë, le Kremlin Bicêtre, France), consulting fees from Nestlé Health Science, Servier, Baxter, BBraun, Fresenius-Kabi, Nutricia, LeCancer and Nutricia, NHC, Novonordisk; Luc Cynober is a shareholder of Citrage Co, member of the Citrage Co Scientific Committee."

"Funding The trial was funded with a Grant from the French Ministry of Health (API14/R/001; Groupement Interrégional de Recherche Clinique et d’Innovation Grand Ouest). The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication."

"Trial registration : ClinicalTrials.gov Identifier NCT02864017 (date of registration: 11 August 2016)."