Clinical trial NCT01802099: Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines
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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Institut National de la Santé Et de la Recherche Médicale, France
name: University Hospital, Tours
First posted: 2013-03-01
Enrollment: 2411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
measure: Mortality rate
timeFrame: 90 days
measure: Ventilator-associated pneumonia rate
timeFrame: until weaning of mechanical ventilation (average: 7 days)
measure: Nosocomial infections rate
timeFrame: until discharge from ICU (average: 10 days)
measure: Length of stay in Intensive Care Unit (ICU)
timeFrame: until discharge from ICU (average: 10 days)
measure: Length of stay in hospital
timeFrame: until discharge from hospital (average: 17 days)
measure: Variations in Sepsis-related Organ Failure Assessment (SOFA) score
timeFrame: first week (7 days) of mechanical ventilation
measure: calories intake
timeFrame: until weaning of mechanical ventilation (average : 7 days)
measure: Proportion of patients given 100% of the calorie target
timeFrame: until weaning of mechanical ventilation (average: 7 days)
measure: cumulative calorie deficit from day 0 to day 7
timeFrame: During the first week (7 days) of mechanical ventilation
measure: Hospital mortality rate
timeFrame: Until discharge from hospital (average : 17 days)
measure: Intensive Care Unit (ICU) mortality rate
timeFrame: until discharge from ICU (average: 10 days)
measure: Acute bowel ischemia rate
timeFrame: until weaning of mechanical ventilation (average: 7 days)
measure: Vomiting rate
timeFrame: until weaning of mechanical ventilation (average: 7 days)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Annecy
country: France
facility: Centre hospitalier d'Annecy
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Besançon
country: France
facility: CHU Besançon-Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: CHU Pellegrin Tripode
city: Chartres
country: France
facility: CH Louis Pasteur
city: Clermont Ferrand
country: France
facility: CHU Gabriel Montpied, Clermont Ferrand
city: Colombes
country: France
facility: CHU Louis Mourier
city: Dieppe
country: France
facility: CH de Dieppe
city: Dijon
country: France
facility: CHU Dijon
city: Garches
country: France
facility: Hôpital Raymond Poincarre
city: Grenoble
country: France
facility: CHU Grenoble
city: La Roche sur Yon
country: France
facility: CHD Vendée - service de réanimation
city: Le Kremlin-Bicêtre
country: France
facility: CHU de Bicêtre
city: Lens
country: France
facility: CH Docteur Schaffner
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: CHU de Lyon- Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Melun
country: France
facility: CH Marc Jacquet
city: Montauban
country: France
facility: CH de Montauban
city: Montreuil
country: France
facility: CHI André Grégoire
city: Mulhouse
country: France
facility: Hôpital Emile Muller
city: Nantes
country: France
facility: CHU de Nantes, Hopital Laennec
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Orléans
country: France
facility: Hôpital de La Source, CHR Orléans
city: Paris
country: France
facility: CHU Saint Louis
city: Paris
country: France
facility: CHU Saint-Antoine
city: Paris
country: France
facility: CHU Paris Cochin
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
city: Paris
country: France
facility: Hôpital Tenon
city: Pointe À Pitre
country: France
facility: CHU Pointe à Pitre - Abymes
city: Poitiers
country: France
facility: CHU Poitiers
city: Rodez
country: France
facility: Centre Hospitalier Jacques Puel
city: Saint Denis
country: France
facility: Hôpital Delafontaine
city: Saint Etienne
country: France
facility: CHU Saint Etienne-Hôpital Nord
city: Saint Malo
country: France
facility: CH de Saint Malo
city: Strasbourg
country: France
facility: CHU de Strasbourg - Nouvel Hôpital Civil
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital de Hautepierre
city: Suresnes
country: France
facility: Hôpital Foch
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHD Vendee
name: Jean Reignier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.