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).
| Title: | 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). |
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| Authors: | Reignier J; Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Nantes, Nantes, France jean.reignier@chu-nantes.fr.; Le Gouge A; INSERM CIC 1415, Centre Hospitalier Regional Universitaire de Tours, Tours, France.; Lascarrou JB; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Nantes, Nantes, France.; Annane D; Service de Médecine Intensive Réanimation, Hôpital Raymond Poincaré, Garches, France.; Argaud L; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Lyon, Lyon, France.; Hourmant Y; Pôle Anesthésie Réanimations, Service d'Anesthésie Réanimation Chirurgicale, CHU Nantes, Nantes, France.; Asfar P; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire d'Angers, Angers, France.; Badie J; Service de Médecine Intensive Réanimation, Hôpital Nord Franche-Comté, Montbeliard, France.; Nay MA; Service de Médecine Intensive Réanimation, Centre Hospitalier Régional d'Orleans Hôpital de La Source, Orleans, France.; Botoc NV; Service de Médecine Intensive Réanimation, Centre Hospitalier de Saint-Malo, Saint-Malo, France.; Brisard L; Service d'Anesthésie Réanimation Chirurgicale, CHU Nantes, Nantes, France.; Bui HN; Service de Médecine Intensive Réanimation, CHU de Bordeaux, Bordeaux, France.; Chatellier D; Service de Médecine Intensive Réanimation, CHU Poitiers, Poitiers, France.; Chauvelot L; Service de Médecine Intensive Réanimation, CHU Lyon, Lyon, France.; Combes A; Service de Médecine Intensive Réanimation, Hôpital Universitaire Pitié Salpêtrière, Paris, France.; Cracco C; Service de Médecine Intensive Réanimation, Centre Hospitalier d'Angouleme, Angouleme, France.; Darmon M; Service de Médecine Intensive Réanimation, Hôpital Saint-Louis, Paris, France.; Das V; Médecine Intensive Réanimation, CHI André Grégoire, Montreuil, France.; Debarre M; Médecine Intensive Réanimation, Centre Hospitalier de Saint Brieuc, Saint Brieuc, France.; Delbove A; Réanimation Polyvalente, Centre Hospitalier Bretagne Atlantique, Vannes, France.; Devaquet J; Medical-Surgical Intensive Care Unit, Hôpital Foch, Suresnes, France.; Voicu S; Médecine Intensive Réanimation, Hopital Lariboisiere, Paris, France.; Aissaoui-Balanant N; Médecine Intensive Réanimation, Hôpital Europeen Georges-Pompidou - Broussais, Paris, France.; Dumont LM; Service de Médecine Intensive Réanimation, Hôpital Louis-Mourier, Colombes, France.; Oziel J; Service de Médecine Intensive Réanimation, Hôpital Avicenne, Bobigny, France.; Gontier O; Service de Médecine Intensive Réanimation, Centre Hospitalier de Chartres, Chartres, France.; Groyer S; Service de Médecine Intensive Réanimation, Centre Hospitalier de Montauban, Montauban, France.; Guidet B; Service de Médecine Intensive Réanimation, Hôpital Saint-Antoine, Paris, France.; Jaber S; Service de Réanimation Chirurgicale, Hôpital Saint-Eloi, Montpellier, France.; Lambiotte F; Service de Médecine Intensive Réanimation, Centre Hospitalier de Valenciennes, Valenciennes, France.; Leroy C; Service de Médecine Intensive Réanimation, Centre Hospitalier Emile Roux, Le Puy en Velay, France.; Letocart P; Service de Médecine Intensive Réanimation, Centre Hospitalier de Rodez, Rodez, France.; Madeux B; Service de Médecine Intensive Réanimation, Centre Hospitalier de Bigorre, Tarbes, France.; Maizel J; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France.; Martinet O; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de La Réunion, Saint-Denis, France.; Martino F; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire Pointe-à-Pitre Abymes, Pointe-a-Pitre, Guadeloupe.; Mercier E; Service de Médecine Intensive Réanimation, Centre Hospitalier Régional Universitaire de Tours, Tours, France.; Mira JP; Service de Médecine Intensive Réanimation, Hôpital Cochin, Paris, France.; Nseir S; Service de Médecine Intensive Réanimation, CHU Lille, Lille, France.; Picard W; Service de Médecine Intensive Réanimation, Centre Hospitalier de Pau, Pau, France.; Piton G; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Besancon, Besancon, France.; Plantefeve G; Service de Médecine Intensive Réanimation, Centre Hospitalier d'Argenteuil, Argenteuil, France.; Quenot JP; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Dijon, Dijon, France.; Renault A; Service de Médecine Intensive Réanimation, CHRU de Brest, Brest, France.; Guérin L; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Bicêtre, Le Kremlin-Bicetre, France.; Richecoeur J; Service de Médecine Intensive Réanimation, Centre Hospitalier de Beauvais, Beauvais, France.; Rigaud JP; Service de Médecine Intensive Réanimation, Centre Hospitalier de Dieppe, Dieppe, France.; Schneider F; Service de Médecine Intensive Réanimation, Hopitaux Universitaires de Strasbourg, Strasbourg, France.; Silva D; Service de Médecine Intensive Réanimation, Centre Hospitalier de Saint Denis, Saint Denis, France.; Sirodot M; Service de Médecine Intensive Réanimation, Centre Hospitalier Annecy Genevois, Epagny Metz-Tessy, France.; Souweine B; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.; Reizine F; Service de Médecine Intensive et Réanimation, Centre Hospitalier Universitaire de Rennes, Rennes, France.; Tamion F; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Rouen, Rouen, France.; Terzi N; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire Grenoble Alpes Hopital Michallon, La Tronche, France.; Thévenin D; Service de Médecine Intensive Réanimation, Centre Hospitalier de Lens, Lens, France.; Thiéry G; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, France.; Thieulot-Rolin N; Service de Médecine Intensive Réanimation, Centre Hospitalier de Melun, Melun, France.; Timsit JF; Service de Médecine Intensive Réanimation, Hôpital Bichat - Claude-Bernard, Paris, France.; Tinturier F; Réanimation Chirurgicale, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France.; Tirot P; Service de Médecine Intensive Réanimation, Centre Hospitalier du Mans, Le Mans, France.; Vanderlinden T; Service de Médecine Intensive Réanimation, Institut Catholique de Lille, Lille, France.; Vinatier I; Service de Médecine Intensive Réanimation, Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France.; Vinsonneau C; Service de Médecine Intensive Réanimation, Centre Hospitalier de Béthune, Bethune, France.; Maugars D; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Nantes, Nantes, France.; Giraudeau B; INSERM CIC 1415, Centre Hospitalier Regional Universitaire de Tours, Tours, France. |
| Source: | BMJ open [BMJ Open] 2021 May 11; Vol. 11 (5), pp. e045041. Date of Electronic Publication: 2021 May 11. |
| Publication Type: | Journal Article; Research Support, Non-U.S. Gov't; Clinical Trial Protocol |
| Language: | English |
| Journal Info: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| MeSH Terms: | COVID-19* ; Diet, Protein-Restricted*; Adult ; Critical Illness ; Humans ; Respiration, Artificial ; SARS-CoV-2 ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic |
| 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.; (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| Competing Interests: | Competing interests: JR had travel and accommodation expenses to attend scientific meetings covered by Baxter and Fresenius. |
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| Contributed Indexing: | Keywords: adult intensive & critical care; clinical trials; nutrition & dietetics |
| Molecular Sequence: | ClinicalTrials.gov NCT03573739 |
| Entry Date(s): | Date Created: 20210513 Date Completed: 20210604 Latest Revision: 20260105 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC8117996 |
| DOI: | 10.1136/bmjopen-2020-045041 |
| PMID: | 33980526 |
| Database: | MEDLINE |
Journal Article; Research Support, Non-U.S. Gov't; Clinical Trial Protocol