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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University Hospital, Tours | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenteral nutrition | Other | Patients 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 | Other | Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral nutrition | Other |
|
| |
| Parenteral nutrition |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | 90 days | |
| Ventilator-associated Pneumonia Rate | until weaning of mechanical ventilation (average: 7 days) | |
| Nosocomial Infections Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Reignier, MD, PhD | CHD Vendee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80054 | France | |||
| CHU d'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25539571 | Background | 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. | |
| 29128300 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parenteral Nutrition | Patients 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. Parenteral nutrition |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2014 |
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| Other |
|
|
Bloodstream infection Urinary tract infection Catheter-related infection Other infections |
| 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) |
| Variations in Sepsis-related Organ Failure Assessment (SOFA) Score | first week (7 days) of mechanical ventilation |
| Calories Intake | until weaning of mechanical ventilation (average : 7 days) |
| Proportion of Patients Given 100% of the Calorie Target | until weaning of mechanical ventilation (average: 7 days) |
| Cumulative Calorie Deficit From Day 0 to Day 7 | During the first week (7 days) of mechanical ventilation |
| Hospital Mortality Rate | Until discharge from hospital (average : 17 days) |
| Intensive Care Unit (ICU) Mortality Rate | until discharge from ICU (average: 10 days) |
| Acute Bowel Ischemia Rate | until weaning of mechanical ventilation (average: 7 days) |
| Vomiting Rate | until weaning of mechanical ventilation (average: 7 days) |
| 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 |
| Result |
| Reignier 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. |
| FG001 |
| Enteral Nutrition |
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. Enteral nutrition |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Parenteral Nutrition | Patients 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. Parenteral nutrition |
| BG001 | Enteral Nutrition | Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. Enteral nutrition |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Posted | Count of Participants | Participants | 28 days |
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| |||||||||||||||||||||||||||||||
| Secondary | Mortality Rate | Patient dead at day 28 are not analysed | Posted | Count of Participants | Participants | 90 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Ventilator-associated Pneumonia Rate | Not Posted | until weaning of mechanical ventilation (average: 7 days) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Nosocomial Infections Rate | Bloodstream infection Urinary tract infection Catheter-related infection Other infections | Not Posted | until discharge from ICU (average: 10 days) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Length of Stay in Intensive Care Unit (ICU) | Not Posted | until discharge from ICU (average: 10 days) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Length of Stay in Hospital | Not Posted | until discharge from hospital (average: 17 days) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Variations in Sepsis-related Organ Failure Assessment (SOFA) Score | Not Posted | first week (7 days) of mechanical ventilation | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Calories Intake | Not Posted | until weaning of mechanical ventilation (average : 7 days) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Given 100% of the Calorie Target | Not Posted | until weaning of mechanical ventilation (average: 7 days) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Calorie Deficit From Day 0 to Day 7 | Not Posted | During the first week (7 days) of mechanical ventilation | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Hospital Mortality Rate | Not Posted | Until discharge from hospital (average : 17 days) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Intensive Care Unit (ICU) Mortality Rate | Not Posted | until discharge from ICU (average: 10 days) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Acute Bowel Ischemia Rate | Not Posted | until weaning of mechanical ventilation (average: 7 days) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Vomiting Rate | Not Posted | until weaning of mechanical ventilation (average: 7 days) | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parenteral Nutrition | Patients 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. Parenteral nutrition | 0 | 1,208 | 0 | 1,208 | ||
| EG001 | Enteral Nutrition | Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. Enteral nutrition | 0 | 1,202 | 0 | 1,202 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jean REIGNIER | CHD Vendée | 0251446572 | +33 | jean.reignier@chd-vendee.fr |
| Jan 5, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012769 | Shock |
| D006963 | Hyperphagia |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| D010288 | Parenteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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