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

This study is ongoing, but not recruiting participants.
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: July 9, 2015
Last verified: July 2015
  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: September 2015
Estimated Primary Completion Date: July 2015 (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

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
Hospices Civils de Lyon
Lyon, France, 69437
CHU de Lyon- Hôpital de la Croix Rousse
Lyon, France, 69004
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 Paris Cochin
Paris, France, 75014
CHU Saint Louis
Paris, France, 75010
CHU Saint-Antoine
Paris, France, 75012
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 - Hôpital de Hautepierre
Strasbourg, France, 67098
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
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
  More Information

No publications provided by Centre Hospitalier Departemental Vendee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 9, 2015
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:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 30, 2015