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Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines (NUTRIREA2)

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ClinicalTrials.gov Identifier: NCT01802099
Recruitment Status : Terminated (stopped on Data Safety and Monitoring Board 's request)
First Posted : March 1, 2013
Last Update Posted : August 26, 2016
Sponsor:
Collaborators:
Ministry of Health, France
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Tours
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Shock Other: Enteral nutrition Other: Parenteral nutrition Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines: Multicenter, Randomized Controlled Trial (NUTRIREA-2)
Study Start Date : March 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
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.
Other: Parenteral nutrition
Other Names:
  • Intravenous nutrition
  • intravenous feeding
Enteral nutrition
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Other: Enteral nutrition
Other Name: Enteral feeding



Primary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: 90 days ]
  2. Ventilator-associated pneumonia rate [ Time Frame: until weaning of mechanical ventilation (average: 7 days) ]
  3. Nosocomial infections rate [ Time Frame: until discharge from ICU (average: 10 days) ]
    Bloodstream infection Urinary tract infection Catheter-related infection Other infections

  4. Length of stay in Intensive Care Unit (ICU) [ Time Frame: until discharge from ICU (average: 10 days) ]
  5. Length of stay in hospital [ Time Frame: until discharge from hospital (average: 17 days) ]
  6. Variations in Sepsis-related Organ Failure Assessment (SOFA) score [ Time Frame: first week (7 days) of mechanical ventilation ]
  7. calories intake [ Time Frame: until weaning of mechanical ventilation (average : 7 days) ]
  8. Proportion of patients given 100% of the calorie target [ Time Frame: until weaning of mechanical ventilation (average: 7 days) ]
  9. cumulative calorie deficit from day 0 to day 7 [ Time Frame: During the first week (7 days) of mechanical ventilation ]
  10. Hospital mortality rate [ Time Frame: Until discharge from hospital (average : 17 days) ]
  11. Intensive Care Unit (ICU) mortality rate [ Time Frame: until discharge from ICU (average: 10 days) ]
  12. Acute bowel ischemia rate [ Time Frame: until weaning of mechanical ventilation (average: 7 days) ]
  13. Vomiting rate [ Time Frame: until weaning of mechanical ventilation (average: 7 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Abdominal surgery within 1 month before inclusion
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802099


Locations
France
CHU Amiens
Amiens, France, 80054
CHU d'Angers
Angers, France, 49933
Centre hospitalier d'Annecy
Annecy, France, 74374
Centre Hospitalier de Beauvais
Beauvais, France, 60021
CHU Besançon-Hôpital Jean Minjoz
Besançon, France, 25000
CHU Pellegrin Tripode
Bordeaux, France, 33076
CH Louis Pasteur
Chartres, France, 28018
CHU Gabriel Montpied, Clermont Ferrand
Clermont Ferrand, France, 63003
CHU Louis Mourier
Colombes, France, 92701
CH de Dieppe
Dieppe, France, 76202
CHU Dijon
Dijon, France, 21079
Hôpital Raymond Poincarre
Garches, France, 92380
CHU Grenoble
Grenoble, France, 38043
CHD Vendée - service de réanimation
La Roche sur Yon, France, 85000
CHU de Bicêtre
Le Kremlin-Bicêtre, France, 94275
CH Docteur Schaffner
Lens, France, 62307
CHU Lille
Lille, France, 59000
CHU de Lyon- Hôpital de la Croix Rousse
Lyon, France, 69004
Hospices Civils de Lyon
Lyon, France, 69437
CH Marc Jacquet
Melun, France, 77000
CH de Montauban
Montauban, France, 82013
CHI André Grégoire
Montreuil, France, 93105
Hôpital Emile Muller
Mulhouse, France, 68100
CHU de Nantes, Hopital Laennec
Nantes, France, 44000
CHU de Nantes - Hôtel Dieu
Nantes, France, 44093
Hôpital de La Source, CHR Orléans
Orléans, France, 45067
CHU Saint Louis
Paris, France, 75010
CHU Saint-Antoine
Paris, France, 75012
CHU Paris Cochin
Paris, France, 75014
Groupe Hospitalier Paris Saint Joseph
Paris, France, 75014
Hôpital Tenon
Paris, France, 75020
CHU Pointe à Pitre - Abymes
Pointe à Pitre, France, 97159
CHU Poitiers
Poitiers, France, 86021
Centre Hospitalier Jacques Puel
Rodez, France, 12000
Hôpital Delafontaine
Saint Denis, France, 93200
CHU Saint Etienne-Hôpital Nord
Saint Etienne, France, 42055
CH de Saint Malo
Saint Malo, France, 35400
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Hôpital Foch
Suresnes, France, 92150
CHU Tours
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Ministry of Health, France
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Tours
Investigators
Principal Investigator: Jean Reignier, MD, PhD CHD Vendee

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Reignier J, Boisramé-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, Guérin 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, Thévenin 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.

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT01802099     History of Changes
Other Study ID Numbers: CHD085-11
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016

Keywords provided by Centre Hospitalier Departemental Vendee:
mechanical ventilation
early enteral nutrition
intensive care unit
early parenteral nutrition
critical care medicine
nosocomial infection
mortality
shock
vasoactive drug

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases