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

Primary Purpose

Acute Respiratory Failure, Shock

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Enteral nutrition
Parenteral nutrition
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Respiratory Failure focused on measuring mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality, shock, vasoactive drug

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens
  • CHU d'Angers
  • Centre hospitalier d'Annecy
  • Centre Hospitalier de Beauvais
  • CHU Besançon-Hôpital Jean Minjoz
  • CHU Pellegrin Tripode
  • CH Louis Pasteur
  • CHU Gabriel Montpied, Clermont Ferrand
  • CHU Louis Mourier
  • CH de Dieppe
  • CHU Dijon
  • Hôpital Raymond Poincarre
  • CHU Grenoble
  • CHD Vendée - service de réanimation
  • CHU de Bicêtre
  • CH Docteur Schaffner
  • CHU Lille
  • CHU de Lyon- Hôpital de la Croix Rousse
  • Hospices Civils de Lyon
  • CH Marc Jacquet
  • CH de Montauban
  • CHI André Grégoire
  • Hôpital Emile Muller
  • CHU de Nantes, Hopital Laennec
  • CHU de Nantes - Hôtel Dieu
  • Hôpital de La Source, CHR Orléans
  • CHU Saint Louis
  • CHU Saint-Antoine
  • CHU Paris Cochin
  • Groupe Hospitalier Paris Saint Joseph
  • Hôpital Tenon
  • CHU Pointe à Pitre - Abymes
  • CHU Poitiers
  • Centre Hospitalier Jacques Puel
  • Hôpital Delafontaine
  • CHU Saint Etienne-Hôpital Nord
  • CH de Saint Malo
  • CHU de Strasbourg - Nouvel Hôpital Civil
  • CHU de Strasbourg - Hôpital de Hautepierre
  • Hôpital Foch
  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Parenteral nutrition

Enteral nutrition

Arm Description

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.

Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

Mortality rate
Ventilator-associated pneumonia rate
Nosocomial infections rate
Bloodstream infection Urinary tract infection Catheter-related infection Other infections
Length of stay in Intensive Care Unit (ICU)
Length of stay in hospital
Variations in Sepsis-related Organ Failure Assessment (SOFA) score
calories intake
Proportion of patients given 100% of the calorie target
cumulative calorie deficit from day 0 to day 7
Hospital mortality rate
Intensive Care Unit (ICU) mortality rate
Acute bowel ischemia rate
Vomiting rate

Full Information

First Posted
February 27, 2013
Last Updated
February 22, 2019
Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01802099
Brief Title
Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines
Acronym
NUTRIREA2
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
stopped on Data Safety and Monitoring Board 's request
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Shock
Keywords
mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality, shock, vasoactive drug

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parenteral nutrition
Arm Type
Other
Arm Description
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.
Arm Title
Enteral nutrition
Arm Type
Other
Arm Description
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
Intervention Type
Other
Intervention Name(s)
Enteral nutrition
Other Intervention Name(s)
Enteral feeding
Intervention Type
Other
Intervention Name(s)
Parenteral nutrition
Other Intervention Name(s)
Intravenous nutrition, intravenous feeding
Primary Outcome Measure Information:
Title
Mortality
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Mortality rate
Time Frame
90 days
Title
Ventilator-associated pneumonia rate
Time Frame
until weaning of mechanical ventilation (average: 7 days)
Title
Nosocomial infections rate
Description
Bloodstream infection Urinary tract infection Catheter-related infection Other infections
Time Frame
until discharge from ICU (average: 10 days)
Title
Length of stay in Intensive Care Unit (ICU)
Time Frame
until discharge from ICU (average: 10 days)
Title
Length of stay in hospital
Time Frame
until discharge from hospital (average: 17 days)
Title
Variations in Sepsis-related Organ Failure Assessment (SOFA) score
Time Frame
first week (7 days) of mechanical ventilation
Title
calories intake
Time Frame
until weaning of mechanical ventilation (average : 7 days)
Title
Proportion of patients given 100% of the calorie target
Time Frame
until weaning of mechanical ventilation (average: 7 days)
Title
cumulative calorie deficit from day 0 to day 7
Time Frame
During the first week (7 days) of mechanical ventilation
Title
Hospital mortality rate
Time Frame
Until discharge from hospital (average : 17 days)
Title
Intensive Care Unit (ICU) mortality rate
Time Frame
until discharge from ICU (average: 10 days)
Title
Acute bowel ischemia rate
Time Frame
until weaning of mechanical ventilation (average: 7 days)
Title
Vomiting rate
Time Frame
until weaning of mechanical ventilation (average: 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Reignier, MD, PhD
Organizational Affiliation
CHD Vendee
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre hospitalier d'Annecy
City
Annecy
ZIP/Postal Code
74374
Country
France
Facility Name
Centre Hospitalier de Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
CHU Besançon-Hôpital Jean Minjoz
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CHU Pellegrin Tripode
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CH Louis Pasteur
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
CHU Gabriel Montpied, Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU Louis Mourier
City
Colombes
ZIP/Postal Code
92701
Country
France
Facility Name
CH de Dieppe
City
Dieppe
ZIP/Postal Code
76202
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Raymond Poincarre
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHD Vendée - service de réanimation
City
La Roche sur Yon
ZIP/Postal Code
85000
Country
France
Facility Name
CHU de Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
CH Docteur Schaffner
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHU de Lyon- Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CH Marc Jacquet
City
Melun
ZIP/Postal Code
77000
Country
France
Facility Name
CH de Montauban
City
Montauban
ZIP/Postal Code
82013
Country
France
Facility Name
CHI André Grégoire
City
Montreuil
ZIP/Postal Code
93105
Country
France
Facility Name
Hôpital Emile Muller
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
CHU de Nantes, Hopital Laennec
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital de La Source, CHR Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
CHU Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
CHU Paris Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
CHU Pointe à Pitre - Abymes
City
Pointe À Pitre
ZIP/Postal Code
97159
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier Jacques Puel
City
Rodez
ZIP/Postal Code
12000
Country
France
Facility Name
Hôpital Delafontaine
City
Saint Denis
ZIP/Postal Code
93200
Country
France
Facility Name
CHU Saint Etienne-Hôpital Nord
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CH de Saint Malo
City
Saint Malo
ZIP/Postal Code
35400
Country
France
Facility Name
CHU de Strasbourg - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU de Strasbourg - Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29128300
Citation
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.
Results Reference
derived
PubMed Identifier
25539571
Citation
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.
Results Reference
derived

Learn more about this trial

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

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