Low versus standard calorie and protein feeding in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3)

Reignier, Jean; Plantefève, Gaëtan; Mira, Jean‐Paul; Argaud, Laurent; Asfar, Pierre; Aïssaoui, Nadia; Badié, Julio; Botoc, Nicolae-Vlad; Brisard, Laurent; Bui, Hoang-Nam; Chatellier, Delphine; Chauvelot, Louis; Combes, Alain; Cracco, Christophe; Darmon, Michaël; Das, Vincent; Débarre, Matthieu; Delbove, Agathe; Devaquet, Jérôme; Dumont, Louis-Marie; Gontier, Olivier; Groyer, Samuel; Guérin, Laurent; Guidet, Bertrand; Hourmant, Yannick; Jaber, Samir; Lambiotte, Fabien; Leroy, C.; Letocart, Philippe; Madeux, Benjamin; Maizel, Julien; Martinet, Olivier; Martino, Frédéric; Maxime, Virginie; Mercier, Emmanuelle; Nay, Mai-Anh; Nseir, Saad; Oziel, Johanna; Picard, Walter; Piton, Gaël; Quenot, Jean-Pierre; Reizine, Florian; Renault, Anne; Richecoeur, Jack; Rigaud, Jean‐Philippe; Schneider, Francis; Silva, Daniel; Sirodot, Michel; Souweine, Bertrand; Tamion, Fabienne; Terzi, Nicolas; Thévenin, Didier; Thiéry, Guillaume; Thieulot-Rolin, Nathalie; Timsit, Jean‐François; Tinturier, F.; Tirot, P.; Vanderlinden, Thierry; Vinatier, Isabelle; Vinsonneau, Christophe; Voicu, Sébastian; Lascarrou, Jean-Baptiste; Gouge, Amélie Le; Contou, Damien; Pajot, Olivier; Jaubert, Paul; Marin, Nathalie; Simon, Marie; Cour, Martin; Mortaza, Satar; Souday, Vincent; Lemerle, Marie; Malfroy, Sylvain; Ferrari, Fernando Berdaguer; Rozec, Bertrand; Gruson, Didier; Sazio, Charline; Champion, Suzanne; Boissier, Florence; Veinstein, Anne; Baboi, Loredana; Richard, Jean‐Christophe; Yonis, Hodane; Guennec, Loïc Le; Lefèvre, Lucie; Chommeloux, Juliette; Hékimian, Guillaume; Lemiale, Virginie; Mariotte, Éric; Valade, Sandrine; Tirolien, Joanna; Fédun, Yannick; Cerf, Charles; Tachon, Guillaume; Roustan, Jérôme; Vimeux, Sylvie; Bonnivard, Michel; Anguel, Nadia; Osman, David; Asehnoune, Karim; Roquilly, Antoine; Belafia, Fouad; Conseil, Matthieu; Cissé, Moussa; Chaouki, Bouras; Espenel, Rémi; Brasse, Christine; Ena, Sébastien; Delahaye, Arnaud; Castanera, Jeremy; Dulac, Thierry; Petua, Philippe; Zerbib, Yoann; Brault, C.; Annane, Djillali; Bounab, Rania; Heming, Nicholas; Boulain, Thierry; Jacquier, Sophie; Muller, Grégoire; Favory, Raphaël; Preau, Sébastien; Poissy, Julien; Massri, Alexandre; Lissonde, Floriane; Winiszewski, Hadrien; Vieille, Thibault; Jacquier, Marine; Labreuche, Julien; Andreu, Pascal; Tadié, Jean‐Marc; Bodénes, Laetitia; Combaux, Danièle; Luis, David; Marchalot, Antoine; Herbrecht, Jean-Étienne; Clère-Jehl, Raphaël; Schnell, David; Aboad, Jérôme; Bougon, David; Escudier, Étienne; Coupez, Elisabeth; Dupuis, Claire; Demailly, Zoe; Galerneau, Louis-Marie; Chelly, Jonathan; Pourcine, Franck; Vong, Ly Van; Abid, S.; Montmollin, Étienne de; Sonneville, Romain; Guitton, Christophe; Chudeau, Nicolas; Landais, Mickaël; Pagès, Vincent; Sejourné, Caroline; Rahmani, Imen; Sbouj, Ghada; Mégarbane, Bruno; Deye, Nicolas; Malissin, Isabelle

doi:10.1016/s2213-2600(23)00092-9

Cited by 95 publications

(36 citation statements)

References 30 publications

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“…However, in contrast to our findings and those of Davies et al ( 33 ), the results of the NUTRIREA-3 trial suggested a significantly longer duration of MV (by 1 day), when protein intake was increased from 0.2 to 0.9 g/kg/d ( 19 ). The reason why we did not observe such a negative effect may be related to differences in the frequency of the leading admission diagnosis (e.g., sepsis was present at admission in about 10% of our patients, but in 60% of the NUTRIREA-3 patients).…”

Section: Discussioncontrasting

confidence: 99%

“…Recently, two randomized trials have addressed this issue. Results from Nutrition en Réanimation (NUTRIREA-3) suggested that increasing daily protein intake from 0.2 to 0.9 g/kg during the first week after ICU admission may significantly prolong the time to weaning ( 19 ). In the EFFORT Protein trial, a further increase of up to 1.6 g protein/kg/d did not further prolong the duration of MV, but most likely increased time to discharge alive from hospital in high-risk ventilated patients ( 20 ).…”

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confidence: 99%

“…However, the external validity of randomized trials may be limited. In the NUTRIREA-3 and EFFORT Protein trials, only 57.5% and 65.1% of eligible patients, respectively, could be randomized ( 19 , 20 ). Therefore, we analyzed a large international database to further substantiate the associations between protein intake and the risk of death in patients requiring MV, or the chance of successful weaning.…”

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confidence: 99%

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Relevance of Protein Intake for Weaning in the Mechanically Ventilated Critically Ill: Analysis of a Large International Database

Hartl,

Kopper,

et al. 2023

Critical Care Medicine

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Objectives: The association between protein intake and the need for mechanical ventilation (MV) is controversial. We aimed to investigate the associations between protein intake and outcomes in ventilated critically ill patients. Design: Analysis of a subset of a large international point prevalence survey of nutritional practice in ICUs. Setting: A total of 785 international ICUs Patients: A total of 12,930 patients had been in the ICU for at least 96 hours and required MV by the fourth day after ICU admission at the latest. Interventions: None. Measurements and Main Results: We modeled associations between the adjusted hazard rate (aHR) of death in patients requiring MV and successful weaning (competing risks), and three categories of protein intake (low: < 0.8 g/kg/d, standard: 0.8–1.2 g/kg/d, high: > 1.2 g/kg/d). We compared five different hypothetical protein diets (an exclusively low protein intake, a standard protein intake given early (days 1–4) or late (days 5–11) after ICU admission, and an early or late high protein intake). There was no evidence that the level of protein intake was associated with time to weaning. However, compared with an exclusively low protein intake, a standard protein intake was associated with a lower hazard of death in MV: minimum aHR 0.60 (95% CI, 0.45–0.80). With an early high intake, there was a trend to a higher risk of death in patients requiring MV: maximum aHR 1.35 (95% CI, 0.99–1.85) compared with a standard diet. Conclusions: The duration of MV does not appear to depend on protein intake, whereas mortality in patients requiring MV may be improved by a standard protein intake. Adverse effects of a high protein intake cannot be excluded.

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Section: Discussioncontrasting

confidence: 99%

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confidence: 99%

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confidence: 99%

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Relevance of Protein Intake for Weaning in the Mechanically Ventilated Critically Ill: Analysis of a Large International Database

Hartl,

Kopper,

et al. 2023

Critical Care Medicine

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“…3 However, determining the optimal caloric and protein targets remains challenging as recent large randomised controlled trials (RCT) have not shown a clear benefit of higher vs lower targets. [4][5][6][7][8] Additionally, two RCTs, the PEPaNIC and EPaNIC studies, showed worse outcomes when insufficient or contraindicated enteral nutrition was supplemented with early parenteral nutrition as compared with withholding parenteral nutrition until 1 week after ICU admission. 9 10 These studies used continuous feeding regimens only, yet there is an increasing evidence from animal and human studies that discontinuous feeding regimens, involving alternating feeding and fasting periods, can protect against cellular harm in cardiovascular and agerelated diseases.…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

Impact of daily cyclic enteral nutrition versus standard continuous enteral nutrition in critically ill patients: a study protocol for a randomised controlled trial in three intensive care units in France (DC-SCENIC)

Callahan,

Parot-Schinkel,

Asfar

et al. 2024

BMJ Open

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IntroductionCurrent guidelines on clinical nutrition of ventilated patients in the intensive care unit (ICU) recommend initiating continuous enteral nutrition within 48 hours of ICU admission when feasible. However, discontinuous feeding regimens, alternating feeding and fasting intervals, may have an impact on clinical and patient centred outcomes. The ongoing "Impact of daily cyclic enteral nutrition versus standard continuous enteral nutrition in critically ill patients" (DC-SCENIC) trial aims to compare standard continuous enteral feeding with daily cyclic enteral feeding over 10 hours to evaluate if implementing a fasting-mimicking diet can decrease organ failure in ventilated patients during the acute phase of ICU management.Methods and analysisDC-SCENIC is a randomised, controlled, multicentre, open-label trial comparing two parallel groups of patients 18 years of age or older receiving invasive mechanical ventilation and having an indication for enteral nutrition through a gastric tube. Enteral feeding is continuous in the control group and administered over 10 hours daily in the intervention group. Both groups receive isocaloric nutrition with 4 g of protein per 100 mL, and have the same 20 kcal/kg/day caloric target. The primary endpoint is the change in the Sequential Organ Failure Assessment score at 7 days compared with the day of inclusion in the study. Secondary outcomes include daily caloric and protein delivery, digestive, respiratory and metabolic tolerance as well as 28-day mortality, duration of mechanical ventilation and ventilator-free days. Outcomes will be analysed on an intention-to-treat basis. Recruitment started in June 2023 in 3 French ICU’s and a sample size of 318 patients is expected by February 2026.Ethics and disseminationThis study received approval from the national ethics review board on 8 November 2022 (Comité de Protection des Personnes Sud-Est VI, registration number 2022-A00827-36). Patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT05627167.

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“…The application of full dose feeding in patients receiving high dose of vasopressors did not result in better prognosis and was associated with a higher rate of complications [ 4 ]. And early calorie and protein restriction was associated with faster recovery and fewer complications [ 5 ]. The detailed doses of vasoactive drugs were not decribed in the present study, and this may bias the results.…”

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confidence: 99%

Letter on “Bioimpedance-assessed muscle wasting and its relation to nutritional intake during the first week of ICU: a pre-planned secondary analysis of Nutriti Study”

Jiang,

2024

Ann. Intensive Care

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Low versus standard calorie and protein feeding in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3)

Cited by 95 publications

References 30 publications

Relevance of Protein Intake for Weaning in the Mechanically Ventilated Critically Ill: Analysis of a Large International Database

Relevance of Protein Intake for Weaning in the Mechanically Ventilated Critically Ill: Analysis of a Large International Database

Impact of daily cyclic enteral nutrition versus standard continuous enteral nutrition in critically ill patients: a study protocol for a randomised controlled trial in three intensive care units in France (DC-SCENIC)

Letter on “Bioimpedance-assessed muscle wasting and its relation to nutritional intake during the first week of ICU: a pre-planned secondary analysis of Nutriti Study”

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