Impact of early low-calorie low-protein versus standard-calorie standard-protein feeding on outcomes of ventilated adults with shock: design and conduct of a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3) - Université Paris Cité Accéder directement au contenu
Article Dans Une Revue BMJ Open Année : 2021

Impact of early low-calorie low-protein versus standard-calorie standard-protein feeding on outcomes of ventilated adults with shock: design and conduct of a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3)

Jean Reignier (1) , Amélie Le Gouge (2) , Jean-Baptiste Lascarrou (1) , Djillali Annane (3) , Laurent Argaud (4) , Yannick Hourmant (1) , Pierre Asfar (5) , Julio Badie (6) , Mai-Anh Nay (7) , Nicolae-Vlad Botoc (8) , Laurent Brisard (1) , Hoang-Nam Bui (9) , Delphine Chatellier (10) , Louis Chauvelot (4) , Alain Combes (11) , Christophe Cracco (12) , Michael Darmon (13) , Vincent Das (14) , Matthieu Debarre (15) , Agathe Delbove (16) , Jérôme Devaquet (17) , Sebastian Voicu (18) , Nadia Aissaoui-Balanant (19) , Louis-Marie Dumont (20) , Johanna Oziel (21) , Olivier Gontier (22) , Samuel Groyer (23) , Bertrand Guidet (24) , Samir Jaber (25, 26) , Fabien Lambiotte (27) , Christophe Leroy (28) , Philippe Letocart (29) , Benjamin Madeux (30) , Julien Maizel (31, 32) , Olivier Martinet (33) , Frédéric Martino (34) , Emmanuelle Mercier (35) , Jean-Paul Mira (36) , Saad Nseir (37) , Walter Picard (38) , Gael Piton (39) , Gaetan Plantefeve (40) , Jean-Pierre Quenot (41) , Anne Renault (42) , Laurent Guérin (43) , Jack Richecoeur (44) , Jean Philippe Rigaud (45) , Francis Schneider (46) , Daniel Silva (47) , Michel Sirodot (48) , Bertrand Souweine (49) , Florian Reizine (50) , Fabienne Tamion (51) , Nicolas Terzi (52) , Didier Thévenin (53) , Guillaume Thiéry (54) , Nathalie Thieulot-Rolin (55) , Jean-François Timsit (56) , François Tinturier (32) , Patrice Tirot (57) , Thierry Vanderlinden (58) , Isabelle Vinatier (59) , Christophe Vinsonneau (60) , Diane Maugars (1) , Bruno Giraudeau (2)
1 Service d'anesthésie et réanimation chirurgicale [Nantes]
2 CIC - Centre d’Investigation Clinique [Tours] CIC 1415
3 Hôpital Raymond Poincaré [AP-HP]
4 Service d'anesthésie-réanimation [Centre Hospitalier Lyon Sud - HCL]
5 CHU d'Angers [Département Urgences]
6 HNFC - Hôpital Nord Franche-Comté [Hôpital de Trévenans]
7 CHRO - Centre Hospitalier Régional d'Orléans
8 CH de Saint-Malo [Broussais]
9 Service Anesthésie - Réanimation [Bordeaux]
10 Service des urgences [CHU Poitiers] = Emergency Department (ER) [Poitiers University Hospital]
11 CHU Pitié-Salpêtrière [AP-HP]
12 CH Angoulême - Centre Hospitalier d'Angoulême
13 Service d'Anesthésie-Réanimation [AP-HP Hôpitaux Saint-Louis Lariboisière]
14 CHI André Gregoire - Centre Hospitalier Intercommunal André Grégoire [Montreuil]
15 CHU de Saint-Brieuc
16 CHBA - Centre hospitalier Bretagne Atlantique (Morbihan)
17 Hôpital Foch [Suresnes]
18 Département d’Anesthésie-Réanimation-SMUR [Hôpital Lariboisière]
19 HEGP - Hôpital Européen Georges Pompidou [APHP]
20 Hôpital Louis Mourier - AP-HP [Colombes]
21 Hôpital Avicenne [AP-HP]
22 Service de Réanimation polyvalente [Chartres]
23 CH Montauban - Centre hospitalier de Montauban
24 CHU Saint-Antoine [AP-HP]
25 PhyMedExp - Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
26 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
27 Centre hospitalier [Valenciennes, Nord]
28 Department of Anesthesiology and Critical Care Medicine, Emile-Roux general hospital, Le Puy-en-Velay
29 Intensive Care Unit, Rodez Hospital, Rodez, France
30 Centre Hospitalier de Bigorre [Tarbes]
31 MP3CV - Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517
32 CHU Amiens-Picardie
33 Service d'Anesthésie-Réanimation – Chirurgie Thoracique et Cardiovasculaire [CHU La Réunion]
34 CHU Pointe-à-Pitre/Abymes [Guadeloupe]
35 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
36 Service de réanimation médicale polyvalente [CHU Cochin]
37 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
38 Centre hospitalier de Pau
39 Service d'anesthésie et réanimation chirurgicale [CHRU de Besançon]
40 Service de réanimation (CH d'Argenteuil)
41 Service d'anesthésie - réanimation chirurgicale [CHU de Dijon]
42 CHU - BREST - DAR - CHRU Brest - Département d'Anesthésie Réanimation
43 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
44 Centre Hospitalier Simone Veil de Beauvais [Beauvais]
45 Service de réanimation polyvalente [Centre Hospitalier de Dieppe]
46 Service de Réanimation Médicale [Strasbourg]
47 Centre Hospitalier de Saint-Denis [Ile-de-France]
48 Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois]
49 Service d'Anésthésie Réanimation [CHU Clermont-Ferrand]
50 Service d'Anesthésie Réanimation [Rennes]
51 Service de Réanimation Médicale [CHU Rouen]
52 Service de Réanimation Médicale [Grenoble]
53 Centre Hospitalier de Lens
54 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
55 CHM - Centre Hospitalier de Melun
56 Service d'anesthésie - réanimation chirurgicale [CHU Bichat]
57 Urgences médicales [CH Le Mans]
58 GHICL - Groupement des Hôpitaux de l'Institut Catholique de Lille
59 Service de réanimation (CH La Roche-sur-Yon)
60 CH Béthune - Centre Hospitalier de Béthune
Djillali Annane
Pierre Asfar
Mai-Anh Nay
Alain Combes
Bertrand Guidet
Florian Reizine
Nicolas Terzi

Résumé

International guidelines include early nutritional support (≤48 hour after admission), 20–25 kcal/kg/day, and 1.2–2 g/kg/day protein at the acute phase of critical illness. Recent data challenge the appropriateness of providing standard amounts of calories and protein during acute critical illness. Restricting calorie and protein intakes seemed beneficial, suggesting a role for metabolic pathways such as autophagy, a potential key mechanism in safeguarding cellular integrity, notably in the muscle, during critical illness. However, the optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding. We hypothesised that nutritional support with calorie and protein restriction during acute critical illness decreased day 90 mortality and/or dependency on intensive care unit (ICU) management in mechanically ventilated patients receiving vasoactive amine therapy for shock, compared with standard calorie and protein targets. Methods and analysis NUTRIREA-3 is a randomised, controlled, multicentre, open-label trial comparing two parallel groups of patients receiving invasive mechanical ventilation and vasoactive amine therapy for shock and given early nutritional support according to one of two strategies: early calorie-protein restriction (6 kcal/kg/day-0.2–0.4 g/kg/day) or standard calorie-protein targets (25 kcal/kg/day, 1.0–1.3 g/kg/day) at the acute phase defined as the first 7 days in the ICU. We will include 3044 patients in 61 French ICUs. Two primary end-points will be evaluated: day 90 mortality and time to ICU discharge readiness. The trial will be considered positive if significant between-group differences are found for one or both alternative primary endpoints. Secondary outcomes include hospital-acquired infections and nutritional, clinical and functional outcomes. Ethics and dissemination The NUTRIREA-3 study has been approved by the appropriate ethics committee. Patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals. Trial registration number NCT03573739 .
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hal-03227563 , version 1 (17-05-2021)

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Jean Reignier, Amélie Le Gouge, Jean-Baptiste Lascarrou, Djillali Annane, Laurent Argaud, et al.. Impact of early low-calorie low-protein versus standard-calorie standard-protein feeding on outcomes of ventilated adults with shock: design and conduct of a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3). BMJ Open, 2021, 11 (5), pp.e045041. ⟨10.1136/bmjopen-2020-045041⟩. ⟨hal-03227563⟩
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