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Enteral versus parenteral early nutrition in ventilated adults with shock : a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2)

Jean Reignier 1, * Julie Boisramé-Helms 2, 3 Laurent Brisard 4 Jean-Baptiste Lascarrou 4 Ali Ait Hssain 5 Nadia Anguel Laurent Argaud 6 Karim Asehnoune 1 Pierre Asfar 7 Frédéric Bellec 8 Vlad Botoc 9 Anne Bretagnol 10 Hoang-Nam Bui 11 Emmanuel Canet 12 Daniel da Silva 13 Michaël Darmon 14 Vincent Das Jérôme Devaquet 15 Michel Djibré 16 Frederique Ganster 17 Maïté Garrouste-Orgeas 18 Stéphane Gaudry Olivier Gontier Claude Guérin Bertrand Guidet 19 Christophe Guitton 20 Jean-Etienne Herbrecht 21 Jean-Claude Lacherade 22 Philippe Letocart Frédéric Martino Virginie Maxime Emmanuelle Mercier Jean-Paul Mira Saad Nseir Gaël Piton Jean-Pierre Quenot 23, 24, 25 Jack Richecoeur Jean-Philippe Rigaud René Robert 26 Nathalie Rolin Carole Schwebel 27 Michel Sirodot François Tinturier Didier Thévenin Bruno Giraudeau 28 Amélie Le Gouge 29 H Dupont M Pierrot F Beloncle D Combaux R Mercier H Winiszewski G Capellier G Hilbert D Gruson P Kalfon B Souweine E Coupez Jd Ricard J Messika F Bougerol Pl Declercq A Dargent A Large D Annane B Clair A Bonadona R Hamidfar C Richard M Henry-Lagarrigue Ay Yehia J Temime S Barrailler R Favory E Parmentier-Decrucq M Jourdain L Baboi M Simon T Baudry M Monchi J Roustan P Bardou A Cottereau P Guiot N Brule M Landais A Roquilly T Boulain D Benzekri B Champigneulle J Tahiri G Preda B Misset V Lemiale L Zafrani M Fartoukh G Thiéry D Chatellier R Coudroy R Chouquer S Gay C Brasse Armelle Delahaye L Ferreira R Vermesch S Chevalier C Quentin Q Maestraggi F Schneider F Meziani C Cerf G Trebbia C Salmon-Gandonnière L. Bodet-Contentin
* Corresponding author
Abstract : Background Whether the route of early feeding affects outcomes of patients with severe critical illnesses is controversial. We hypothesised that outcomes were better with early first-line enteral nutrition than with early first-line parenteral nutrition. Methods In this randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2 trial) done at 44 French intensive-care units (ICUs), adults (18 years or older) receiving invasive mechanical ventilation and vasopressor support for shock were randomly assigned (1:1) to either parenteral nutrition or enteral nutrition, both targeting normocaloric goals (20–25 kcal/kg per day), within 24 h after intubation. Randomisation was stratified by centre using permutation blocks of variable sizes. Given that route of nutrition cannot be masked, blinding of the physicians and nurses was not feasible. Patients receiving parenteral nutrition could be switched to enteral nutrition after at least 72 h in the event of shock resolution (no vasopressor support for 24 consecutive hours and arterial lactate <2 mmol/L). The primary endpoint was mortality on day 28 after randomisation in the intention-to-treat-population. This study is registered with ClinicalTrials.gov, number NCT01802099. Findings After the second interim analysis, the independent Data Safety and Monitoring Board deemed that completing patient enrolment was unlikely to significantly change the results of the trial and recommended stopping patient recruitment. Between March 22, 2013, and June 30, 2015, 2410 patients were enrolled and randomly assigned; 1202 to the enteral group and 1208 to the parenteral group. By day 28, 443 (37%) of 1202 patients in the enteral group and 422 (35%) of 1208 patients in the parenteral group had died (absolute difference estimate 2·0%; [95% CI −1·9 to 5·8]; p=0·33). Cumulative incidence of patients with ICU-acquired infections did not differ between the enteral group (173 [14%]) and the parenteral group (194 [16%]; hazard ratio [HR] 0·89 [95% CI 0·72–1·09]; p=0·25). Compared with the parenteral group, the enteral group had higher cumulative incidences of patients with vomiting (406 [34%] vs 246 [20%]; HR 1·89 [1·62–2·20]; p<0·0001), diarrhoea (432 [36%] vs 393 [33%]; 1·20 [1·05–1·37]; p=0·009), bowel ischaemia (19 [2%] vs five [<1%]; 3·84 [1·43–10·3]; p=0·007), and acute colonic pseudo-obstruction (11 [1%] vs three [<1%]; 3·7 [1·03–13·2; p=0·04). Interpretation In critically ill adults with shock, early isocaloric enteral nutrition did not reduce mortality or the risk of secondary infections but was associated with a greater risk of digestive complications compared with early isocaloric parenteral nutrition. Funding La Roche-sur-Yon Departmental Hospital and French Ministry of Health. Copyright © 2017 Elsevier Ltd. All rights reserved.
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Submitted on : Monday, January 15, 2018 - 11:11:37 AM
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Jean Reignier, Julie Boisramé-Helms, Laurent Brisard, Jean-Baptiste Lascarrou, Ali Ait Hssain, et al.. Enteral versus parenteral early nutrition in ventilated adults with shock : a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). The Lancet, Elsevier, 2018, 391 (10116), pp.133 - 143. ⟨10.1016/S0140-6736(17)32146-3⟩. ⟨hal-01684095⟩

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