Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines
NUTRIREA2
1 other identifier
interventional
2,410
1 country
41
Brief Summary
The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Typical duration for not_applicable
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
January 22, 2026
CompletedApril 16, 2026
March 1, 2026
2.3 years
February 27, 2013
January 2, 2026
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
28 days
Secondary Outcomes (13)
Mortality Rate
90 days
Ventilator-associated Pneumonia Rate
until weaning of mechanical ventilation (average: 7 days)
Nosocomial Infections Rate
until discharge from ICU (average: 10 days)
Length of Stay in Intensive Care Unit (ICU)
until discharge from ICU (average: 10 days)
Length of Stay in Hospital
until discharge from hospital (average: 17 days)
- +8 more secondary outcomes
Study Arms (2)
Parenteral nutrition
OTHERPatients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level \< 2 mmol/l). After Day 7, all patients will be fed via the enteral route.
Enteral nutrition
OTHERPatients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Interventions
Eligibility Criteria
You may qualify if:
- Invasive mechanical ventilation expected to be required more than 48 hours
- Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation
- Treatment with vasoactive drug administered via a central venous catheter
- Age over 18 years
- Signed information
You may not qualify if:
- History of esophageal, gastric, duodenal or pancreatic surgery
- Bleeding from the esophagus, stomach or bowel
- enteral nutrition via gastrostomy or jejunostomy
- pregnancy
- Treatment-limitation decisions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ministry of Health, Francecollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- University Hospital, Tourscollaborator
- Centre Hospitalier Departemental Vendeelead
Study Sites (41)
CHU Amiens
Amiens, 80054, France
CHU d'Angers
Angers, 49933, France
Centre hospitalier d'Annecy
Annecy, 74374, France
Centre Hospitalier de Beauvais
Beauvais, 60021, France
CHU Besançon-Hôpital Jean Minjoz
Besançon, 25000, France
CHU Pellegrin Tripode
Bordeaux, 33076, France
CH Louis Pasteur
Chartres, 28018, France
CHU Gabriel Montpied, Clermont Ferrand
Clermont-Ferrand, 63003, France
CHU Louis Mourier
Colombes, 92701, France
CH de Dieppe
Dieppe, 76202, France
CHU Dijon
Dijon, 21079, France
Hôpital Raymond Poincarre
Garches, 92380, France
CHU Grenoble
Grenoble, 38043, France
CHD Vendée - service de réanimation
La Roche-sur-Yon, 85000, France
CHU de Bicêtre
Le Kremlin-Bicêtre, 94275, France
CH Docteur Schaffner
Lens, 62307, France
CHU Lille
Lille, 59000, France
CHU de Lyon- Hôpital de la Croix Rousse
Lyon, 69004, France
Hospices Civils de Lyon
Lyon, 69437, France
CH Marc Jacquet
Melun, 77000, France
CH de Montauban
Montauban, 82013, France
CHI André Grégoire
Montreuil, 93105, France
Hôpital Emile Muller
Mulhouse, 68100, France
CHU de Nantes, Hopital Laennec
Nantes, 44000, France
CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
Hôpital de La Source, CHR Orléans
Orléans, 45067, France
CHU Saint Louis
Paris, 75010, France
CHU Saint-Antoine
Paris, 75012, France
CHU Paris Cochin
Paris, 75014, France
Groupe Hospitalier Paris Saint Joseph
Paris, 75014, France
Hôpital Tenon
Paris, 75020, France
CHU Pointe à Pitre - Abymes
Point À Pitre, 97110, France
CHU Poitiers
Poitiers, 86021, France
Centre Hospitalier Jacques Puel
Rodez, 12000, France
Hôpital Delafontaine
Saint-Denis, 93200, France
CHU Saint Etienne-Hôpital Nord
Saint-Etienne, 42055, France
CH de Saint Malo
St-Malo, 35400, France
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67091, France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098, France
Hôpital Foch
Suresnes, 92150, France
CHU Tours
Tours, 37044, France
Related Publications (2)
Brisard L, Le Gouge A, Lascarrou JB, Dupont H, Asfar P, Sirodot M, Piton G, Bui HN, Gontier O, Hssain AA, Gaudry S, Rigaud JP, Quenot JP, Maxime V, Schwebel C, Thevenin D, Nseir S, Parmentier E, El Kalioubie A, Jourdain M, Leray V, Rolin N, Bellec F, Das V, Ganster F, Guitton C, Asehnoune K, Bretagnol A, Anguel N, Mira JP, Canet E, Guidet B, Djibre M, Misset B, Robert R, Martino F, Letocart P, Silva D, Darmon M, Botoc V, Herbrecht JE, Meziani F, Devaquet J, Mercier E, Richecoeur J, Martin S, Greau E, Giraudeau B, Reignier J. 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). Trials. 2014 Dec 23;15:507. doi: 10.1186/1745-6215-15-507.
PMID: 25539571BACKGROUNDReignier J, Boisrame-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guerin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thevenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.
PMID: 29128300RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Jean REIGNIER
- Organization
- CHD Vendée
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Reignier, MD, PhD
CHD Vendee
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2013
First Posted
March 1, 2013
Study Start
March 1, 2013
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
April 16, 2026
Results First Posted
January 22, 2026
Record last verified: 2026-03