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)
Year: 2021
Type: article
Study design: Study Protocol
Abstract: INTRODUCTION: 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.
Source: BMJ Open
Authors: Jean Reignier, Amélie Le Gouge, Jean-Baptiste Lascarrou, Djillali Annane, Laurent Argaud, Yannick Hourmant, Pierre Asfar, Julio Badie, Mai-Anh Nay, Nicolae-Vlad Botoc, Laurent Brisard, Hoang-Nam Bui, Delphine Chatellier, Louis Chauvelot, Alain Combes, Christophe Cracco, Michael Darmon, Vincent Das, Matthieu Debarre, Agathe Delbove, Jérôme Devaquet, Sebastian Voicu, Nadia Aissaoui-Balanant, Louis-Marie Dumont, Johanna Oziel, Olivier Gontier, Samuel Groyer, Bertrand Guidet, Samir Jaber, Fabien Lambiotte, Christophe Leroy, Philippe Letocart, Benjamin Madeux, Julien Maizel, Olivier Martinet, Frédéric Martino, Emmanuelle Mercier, Jean-Paul Mira, Saad Nseir, Walter Picard, Gael Piton, Gaetan Plantefeve, Jean-Pierre Quenot, Anne Renault, Laurent Guérin, Jack Richecoeur, Jean Philippe Rigaud, Francis Schneider, Daniel Silva, Michel Sirodot, Bertrand Souweine, Florian Reizine, Fabienne Tamion, Nicolas Terzi, Didier Thévenin, Guillaume Thiéry, Nathalie Thieulot-Rolin, Jean-François Timsit, François Tinturier, Patrice Tirot, Thierry Vanderlinden, Isabelle Vinatier, Christophe Vinsonneau, Diane Maugars, Bruno Giraudeau
Institutions: Centre Hospitalier Universitaire de Nantes, Inserm, Centre Hospitalier Universitaire de Tours, Clinical Investigation Center Plurithematic Tours, Nantes Université, Assistance Publique – Hôpitaux de Paris, Hôpital Raymond-Poincaré, Hospices Civils de Lyon, Hôpital Lyon Sud, Centre Hospitalier Universitaire d'Angers, L'Hôpital Nord Franche-Comté, Centre hospitalier universitaire d'Orléans, Centre Hospitalier de Saint-Malo, Centre Hospitalier Universitaire de Bordeaux, Centre Hospitalier Universitaire de Poitiers, Pitié-Salpêtrière Hospital, Centre Hospitalier d'Angoulême, Hôpital Lariboisière, Hôpital Saint-Louis, Centre Hospitalier Intercommunal André Grégoire Montreuil, Centre Hospitalier de Saint-Brieuc, Centre hospitalier Bretagne Atlantique, Hôpital Foch, Hôpital Européen Georges-Pompidou, Hôpital Louis-Mourier, Hôpital Avicenne, Les Hôpitaux de Chartres, Hôpital Saint-Antoine, Physiologie et Médecine Expérimentale du Coeur et des Muscles, Centre Hospitalier Universitaire de Montpellier, Hôpital Saint Eloi, Hôpital Arnaud de Villeneuve, Centre Hospitalier de Valenciennes, Centre hospitalier Emile Roux, Centre Hospitalier de Bigorre, Centre Hospitalier Universitaire Amiens-Picardie, Mécanismes physiopathologiques et conséquences des calcifications cardiovasculaires, Université de Picardie Jules Verne, Centre Hospitalier Universitaire de La Réunion, Centre Hospitalier Universitaire Pointe-à-Pitre, Hôpital Cochin, Centre Hospitalier Universitaire de Lille, Centre Hospitalier De Pau, Centre Hospitalier Universitaire de Besançon, Centre Hospitalier Victor Dupouy, CHU Dijon Bourgogne, Centre Hospitalier Régional Universitaire de Brest, Bicêtre Hospital, Centre Hospitalier de Beauvais, Hôpitaux Universitaires de Strasbourg, Hôpital Civil, Strasbourg, Centre Hospitalier Saint-Denis, Centre Hospitalier Annecy Genevois, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Pontchaillou, Centre Hospitalier Universitaire de Rennes, Centre Hospitalier Universitaire de Rouen, Centre Hospitalier Universitaire de Grenoble, Hôpital Albert Michallon, Centre Hospitalier de Lens, Centre Hospitalier Universitaire de Saint-Étienne, Melun Hospital, Hôpital Bichat-Claude-Bernard, Centre Hospitalier du Mans, Groupe Hospitalier de l'Institut Catholique de Lille, Centre Hospitalier Départemental Vendée, Centre Hospitalier de Béthune
Language: English
Subfield: Nutrition and Dietetics
Field: Nursing
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
OpenAlex ID: W3162318924