| Title: |
Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2) |
| Authors: |
Brisard, Laurent; Le Gouge, Amélie; Lascarrou, Jean-Baptiste; Dupont, Hervé; Asfar, Pierre; Sirodot, Michel; Piton, Gael; Bui, Hoang-Nam; Gontier, Olivier; Ait Hssain, Ali; Gaudry, Stéphane; Rigaud, Jean-Philippe; Quenot, Jean-Pierre; Maxime, Virginie; Schwebel, Carole; Thevenin, D.; Nseir, Saad; Parmentier, Erika; El Kalioubi, A; Jourdain, M.; Leray, V.; Rolin, Nathalie; Bellec, Frédéric; Das, Vincent; Ganster, Frédérique; Guitton, Christophe; Asehnoune, Karim; Bretagnol, Anne; Anguel, Nadia; Mira, Jean-Paul; Canet, Emmanuel; Guidet, Bertrand; Djibre, Michel; Misset, Benoit; Robert, René; Martino, Frédéric; Letocart, Philippe; Silva, D.; Darmon, Michael; Botoc, Vlad; Herbrecht, Jean-Etienne; Meziani, Ferhat; Devaquet, Jérome; Mercier, Emmanuelle; Richecoeur, Jack; Martin, Stéphanie; Greau, E.; Giraudeau, Bruno; Reignier, Jean |
| Contributors: |
Hôpital Guillaume-et-René-Laennec Saint-Herblain; Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); Thérapeutiques cliniques et expérimentales des infections (EA 3826) (EA 3826); Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE); Université de Nantes (UN)-Université de Nantes (UN); Centre d’Investigation Clinique CHRU Tours (CIC 1415); Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre Hospitalier Départemental Les Oudairies; CHU La Roche sur Yon; CHU Amiens-Picardie; Centre Hospitalier Universitaire d'Angers (CHU Angers); Centre Hospitalier Annecy-Genevois Saint-Julien-en-Genevois; Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon); Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux); Hôpitaux de Chartres Chartres; CHU Clermont-Ferrand; Hôpital Louis Mourier - AP-HP Colombes; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)); Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré Paris; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité); Hôpital de Dieppe; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon); Lipides - Nutrition - Cancer (U866) (LNC); Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA); Hôpital Raymond Poincaré AP-HP; CHU de Grenoble-Alpes - Centre Hospitalier Universitaire CHU Grenoble (CHUGA); Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Centre Hospitalier Lyon Sud CHU - HCL (CHLS); Hospices Civils de Lyon (HCL); Centre Hospitalier de Melun (CHM); Hopital Montauban; Centre Hospitalier Intercommunal André Grégoire Montreuil (CHI André Gregoire); Centre Hospitalier Emile Muller Mulhouse (CH E.Muller Mulhouse); Groupe Hospitalier de Territoire Haute Alsace (GHTHA); Hôtel-Dieu de Nantes; Centre Hospitalier Regional d'Orléans (CHRO); Hôpital Bicêtre AP-HP, Le Kremlin-Bicêtre; Hôpital Cochin AP-HP; Hopital Saint-Louis AP-HP (AP-HP); CHU Saint-Antoine AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); CHU Tenon AP-HP; Centre hospitalier Saint-Joseph Paris; Groupe Hospitalier Paris Saint-Joseph (hpsj); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie ); CHU Pointe-à-Pitre / Abymes Guadeloupe; Centre Hospitalier Rodez; Hôpital de Saint-Denis; Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E); CH de Saint-Malo Broussais; Centre Hospitalier Universitaire Strasbourg (CHU Strasbourg); Hôpitaux Universitaires de Strasbourg (HUS); Hôpital Foch Suresnes; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); CH Beauvais; Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée); Université de Tours (UT); PRES Centre-Val de Loire Université |
| Source: |
ISSN: 1745-6215 ; Trials ; https://univ-angers.hal.science/hal-03404020 ; Trials, 2014, 15, pp.507. ⟨10.1186/1745-6215-15-507⟩. |
| Publisher Information: |
CCSD; BioMed Central |
| Publication Year: |
2014 |
| Collection: |
Université François-Rabelais de Tours: HAL |
| Subject Terms: |
Critical illness; Mechanical ventilation; Mortality; Nosocomial infection; Parenteral nutrition; Shock; Vasoactive drugs; Enteral nutrition; [SDV]Life Sciences [q-bio] |
| Description: |
International audience ; BACKGROUND: Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation (IMV) and the most commonly prescribed treatment in intensive care units (ICUs). International guidelines consistently indicate that enteral nutrition (EN) should be preferred over parenteral nutrition (PN) whenever possible and started as early as possible. However, no adequately designed study has evaluated whether a specific nutritional modality is associated with decreased mortality. The primary goal of this trial is to assess the hypothesis that early first-line EN, as compared to early first-line PN, decreases day 28 all-cause mortality in patients receiving IMV and vasoactive drugs for shock. METHODS/DESIGN: The NUTRIREA-2 study is a multicenter, open-label, parallel-group, randomized controlled trial comparing early PN versus early EN in critically ill patients requiring IMV for an expected duration of at least 48 hours, combined with vasoactive drugs, for shock. Patients will be allocated at random to first-line PN for at least 72 hours or to first-line EN. In both groups, nutritional support will be started within 24 hours after IMV initiation. Calorie targets will be 20 to 25 kcal/kg/day during the first week, then 25 to 30 kcal/kg/day thereafter. Patients receiving PN may be switched to EN after at least 72 hours in the event of shock resolution (no vasoactive drugs for 24 consecutive hours and arterial lactic acid level below 2 mmol/L). On day 7, all patients receiving PN and having no contraindications to EN will be switched to EN. In both groups, supplemental PN may be added to EN after day 7 in patients with persistent intolerance to EN and inadequate calorie intake. We plan to recruit 2,854 patients at 44 participating ICUs. DISCUSSION: The NUTRIREA-2 study is the first large randomized controlled trial designed to assess the hypothesis that early EN improves survival compared to early PN in ICU patients. Enrollment started on 22 March 2013 and is expected ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/25539571; OKINA: ua8278; PUBMED: 25539571; PUBMEDCENTRAL: PMC4307984 |
| DOI: |
10.1186/1745-6215-15-507 |
| Availability: |
https://univ-angers.hal.science/hal-03404020; https://univ-angers.hal.science/hal-03404020v1/document; https://univ-angers.hal.science/hal-03404020v1/file/1745-6215-15-507.pdf; https://doi.org/10.1186/1745-6215-15-507 |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.C46C24A |
| Database: |
BASE |