Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines
NCT ID: NCT01802099
Last Updated: 2019-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2411 participants
INTERVENTIONAL
2013-03-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
Enteral nutrition
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Enteral nutrition
Interventions
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Enteral nutrition
Parenteral nutrition
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Current inclusion in a trial on comparison between enteral and parenteral nutrition
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Tours
OTHER
Centre Hospitalier Departemental Vendee
OTHER
Responsible Party
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Principal Investigators
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Jean Reignier, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHD Vendee
Locations
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CHU Amiens
Amiens, , France
CHU d'Angers
Angers, , France
Centre hospitalier d'Annecy
Annecy, , France
Centre Hospitalier de Beauvais
Beauvais, , France
CHU Besançon-Hôpital Jean Minjoz
Besançon, , France
CHU Pellegrin Tripode
Bordeaux, , France
CH Louis Pasteur
Chartres, , France
CHU Gabriel Montpied, Clermont Ferrand
Clermont-Ferrand, , France
CHU Louis Mourier
Colombes, , France
CH de Dieppe
Dieppe, , France
CHU Dijon
Dijon, , France
Hôpital Raymond Poincarre
Garches, , France
CHU Grenoble
Grenoble, , France
CHD Vendée - service de réanimation
La Roche-sur-Yon, , France
CHU de Bicêtre
Le Kremlin-Bicêtre, , France
CH Docteur Schaffner
Lens, , France
CHU Lille
Lille, , France
CHU de Lyon- Hôpital de la Croix Rousse
Lyon, , France
Hospices Civils de Lyon
Lyon, , France
CH Marc Jacquet
Melun, , France
CH de Montauban
Montauban, , France
CHI André Grégoire
Montreuil, , France
Hôpital Emile Muller
Mulhouse, , France
CHU de Nantes, Hopital Laennec
Nantes, , France
CHU de Nantes - Hôtel Dieu
Nantes, , France
Hôpital de La Source, CHR Orléans
Orléans, , France
CHU Saint Louis
Paris, , France
CHU Saint-Antoine
Paris, , France
CHU Paris Cochin
Paris, , France
Groupe Hospitalier Paris Saint Joseph
Paris, , France
Hôpital Tenon
Paris, , France
CHU Pointe à Pitre - Abymes
Pointe à Pitre, , France
CHU Poitiers
Poitiers, , France
Centre Hospitalier Jacques Puel
Rodez, , France
Hôpital Delafontaine
Saint-Denis, , France
CHU Saint Etienne-Hôpital Nord
Saint-Etienne, , France
CH de Saint Malo
St-Malo, , France
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, , France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
Hôpital Foch
Suresnes, , France
CHU Tours
Tours, , France
Countries
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References
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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.
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.
Other Identifiers
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CHD085-11
Identifier Type: -
Identifier Source: org_study_id
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