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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre Hospitalier Departemental Vendee
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
ClinicalTrials.gov Identifier:
NCT01802099
First received: February 27, 2013
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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 Intervention
Acute Respiratory Failure
Shock
Other: Enteral nutrition
Other: Parenteral nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Departemental Vendee:

Primary Outcome Measures:
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality rate [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Ventilator-associated pneumonia rate [ Time Frame: until weaning of mechanical ventilation (average: 7 days) ] [ Designated as safety issue: Yes ]
  • Nosocomial infections rate [ Time Frame: until discharge from ICU (average: 10 days) ] [ Designated as safety issue: Yes ]
    Bloodstream infection Urinary tract infection Catheter-related infection Other infections

  • Length of stay in Intensive Care Unit (ICU) [ Time Frame: until discharge from ICU (average: 10 days) ] [ Designated as safety issue: No ]
  • Length of stay in hospital [ Time Frame: until discharge from hospital (average: 17 days) ] [ Designated as safety issue: No ]
  • Variations in Sepsis-related Organ Failure Assessment (SOFA) score [ Time Frame: first week (7 days) of mechanical ventilation ] [ Designated as safety issue: No ]
  • calories intake [ Time Frame: until weaning of mechanical ventilation (average : 7 days) ] [ Designated as safety issue: No ]
  • Proportion of patients given 100% of the calorie target [ Time Frame: until weaning of mechanical ventilation (average: 7 days) ] [ Designated as safety issue: No ]
  • cumulative calorie deficit from day 0 to day 7 [ Time Frame: During the first week (7 days) of mechanical ventilation ] [ Designated as safety issue: No ]
  • Hospital mortality rate [ Time Frame: Until discharge from hospital (average : 17 days) ] [ Designated as safety issue: Yes ]
  • Intensive Care Unit (ICU) mortality rate [ Time Frame: until discharge from ICU (average: 10 days) ] [ Designated as safety issue: Yes ]
  • Acute bowel ischemia rate [ Time Frame: until weaning of mechanical ventilation (average: 7 days) ] [ Designated as safety issue: Yes ]
  • Vomiting rate [ Time Frame: until weaning of mechanical ventilation (average: 7 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 2854
Study Start Date: March 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • parenteral nutrition
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802099

Contacts
Contact: Jean Reignier, MD, PhD 0251446212 jean.reignier@chd-vendee.fr

Locations
France
CHU Amiens Recruiting
Amiens, France, 80054
Principal Investigator: Hervé Dupont, MD         
CHU d'Angers Recruiting
Angers, France, 49933
Principal Investigator: Pierre Asfar, MD         
Centre hospitalier d'Annecy Recruiting
Annecy, France, 74374
Principal Investigator: Michel Sirodot, MD         
Centre Hospitalier de Beauvais Recruiting
Beauvais, France, 60021
Principal Investigator: Jack Richecoeur, MD         
CHU Besançon-Hôpital Jean Minjoz Recruiting
Besançon, France, 25000
Principal Investigator: Gael Piton         
CHU Pellegrin Tripode Recruiting
Bordeaux, France, 33076
Principal Investigator: Hoang Nam Bui, MD         
CH Louis Pasteur Recruiting
Chartres, France, 28018
Principal Investigator: Olivier Gontier, MD         
CHU Gabriel Montpied, Clermont Ferrand Recruiting
Clermont Ferrand, France, 63003
Principal Investigator: Ali Ait Hssain, MD         
CHU Louis Mourier Recruiting
Colombes, France, 92701
Principal Investigator: Stephane Gaudry, MD         
CH de Dieppe Recruiting
Dieppe, France, 76202
Principal Investigator: Jean-Philippe Rigaud, MD         
CHU Dijon Recruiting
Dijon, France, 21079
Principal Investigator: Jean-Pierre Quenot, MD         
Hôpital Raymond Poincarre Recruiting
Garches, France, 92380
Principal Investigator: Djillali Annane, MD         
CHU Grenoble Recruiting
Grenoble, France, 38043
Principal Investigator: Jean-François Timsit, MD         
CHD Vendée - service de réanimation Recruiting
La Roche sur Yon, France, 85000
Contact: Jerome Dimet, PharmD       jerome.dimet@chd-vendee.fr   
Contact: Stephanie Martin, PharmD    +33 (0)2 51 44 64 83    stephanie.martin@chd-vendee.fr   
Principal Investigator: Jean Reignier, MD, PhD         
CHU de Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94275
Principal Investigator: Nadia Anguel, MD         
CH Docteur Schaffner Recruiting
Lens, France, 62307
Principal Investigator: Didier Thevenin, MD         
CHU Lille Recruiting
Lille, France, 59000
Principal Investigator: Saad Nseir, MD         
CHU de Lyon- Hôpital de la Croix Rousse Recruiting
Lyon, France, 69004
Principal Investigator: Véronique Leray, MD         
CH Marc Jacquet Recruiting
Melun, France, 77000
Principal Investigator: Nathalie Rolin, MD         
CH de Montauban Recruiting
Montauban, France, 82013
Principal Investigator: Frédéric Bellec         
CHI André Grégoire Recruiting
Montreuil, France, 93105
Principal Investigator: Vincent Das, MD         
Hôpital Emile Muller Recruiting
Mulhouse, France, 68100
Principal Investigator: Frédérique Ganster, MD         
CHU de Nantes - Hôtel Dieu Recruiting
Nantes, France, 44093
Principal Investigator: Antoine Roquilly         
CHU de Nantes, Hopital Laennec Recruiting
Nantes, France, 44000
Principal Investigator: Raphael Cinotti, MD         
Sub-Investigator: Laurent Brisard, MD         
CHU de Nantes - Hôtel Dieu Recruiting
Nantes, France, 44093
Principal Investigator: Christophe Guitton, MD         
Hôpital de La Source, CHR Orléans Recruiting
Orléans, France, 45067
Principal Investigator: Thierry Boulain, MD         
Groupe Hospitalier Paris Saint Joseph Recruiting
Paris, France, 75014
Principal Investigator: Benoit Misset, MD         
CHU Paris Cochin Recruiting
Paris, France, 75014
Principal Investigator: Jean-Paul Mira, MD         
Hôpital Tenon Recruiting
Paris, France, 75020
Principal Investigator: Michel Djibre, MD         
CHU Saint-Antoine Recruiting
Paris, France, 75012
Principal Investigator: Bertrand Guidet, MD         
CHU Saint Louis Recruiting
Paris, France, 75010
Principal Investigator: Emmanuel Canet, MD         
CHU Pointe à Pitre - Abymes Recruiting
Pointe à Pitre, France, 97159
Principal Investigator: Guillaume Thiery, MD         
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: , CRA         
Principal Investigator: René Robert, MD         
Centre Hospitalier Jacques Puel Recruiting
Rodez, France, 12000
Principal Investigator: Philippe Letocart, MD         
Hôpital Delafontaine Recruiting
Saint Denis, France, 93200
Principal Investigator: Daniel Silva, MD         
CHU Saint Etienne-Hôpital Nord Recruiting
Saint Etienne, France, 42055
Principal Investigator: Michael Darmon, MD         
CH de Saint Malo Recruiting
Saint Malo, France, 35400
Principal Investigator: Vlad Botoc, MD         
CHU de Strasbourg - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Principal Investigator: Jean-Etienne Herbrecht, MD         
CHU de Strasbourg - Nouvel Hôpital Civil Recruiting
Strasbourg, France, 67091
Principal Investigator: Ferhat Meziani, MD         
Hôpital Foch Recruiting
Suresnes, France, 92150
Principal Investigator: Jérome Devaquet, MD         
CHU Tours Recruiting
Tours, France, 37044
Principal Investigator: Emmanuelle Mercier, MD         
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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT01802099     History of Changes
Other Study ID Numbers: CHD085-11
Study First Received: February 27, 2013
Last Updated: June 27, 2014
Health Authority: France: Institutional Ethical Committee
France: French Data Protection Authority

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:
Shock
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on July 22, 2014