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

Acute Respiratory Failure Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01802099
• Other study ID #: CHD085-11
• Status: Terminated
• Phase: N/A
• Start date: March 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2019
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2411
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Shock

Intervention

Other:
• Enteral nutrition

• Parenteral nutrition

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU d'Angers	Angers
France	Centre hospitalier d'Annecy	Annecy
France	Centre Hospitalier de Beauvais	Beauvais
France	CHU Besançon-Hôpital Jean Minjoz	Besançon
France	CHU Pellegrin Tripode	Bordeaux
France	CH Louis Pasteur	Chartres
France	CHU Gabriel Montpied, Clermont Ferrand	Clermont Ferrand
France	CHU Louis Mourier	Colombes
France	CH de Dieppe	Dieppe
France	CHU Dijon	Dijon
France	Hôpital Raymond Poincarre	Garches
France	CHU Grenoble	Grenoble
France	CHD Vendée - service de réanimation	La Roche sur Yon
France	CHU de Bicêtre	Le Kremlin-Bicêtre
France	CH Docteur Schaffner	Lens
France	CHU Lille	Lille
France	CHU de Lyon- Hôpital de la Croix Rousse	Lyon
France	Hospices Civils de Lyon	Lyon
France	CH Marc Jacquet	Melun
France	CH de Montauban	Montauban
France	CHI André Grégoire	Montreuil
France	Hôpital Emile Muller	Mulhouse
France	CHU de Nantes - Hôtel Dieu	Nantes
France	CHU de Nantes, Hopital Laennec	Nantes
France	Hôpital de La Source, CHR Orléans	Orléans
France	CHU Paris Cochin	Paris
France	CHU Saint Louis	Paris
France	CHU Saint-Antoine	Paris
France	Groupe Hospitalier Paris Saint Joseph	Paris
France	Hôpital Tenon	Paris
France	CHU Pointe à Pitre - Abymes	Pointe À Pitre
France	CHU Poitiers	Poitiers
France	Centre Hospitalier Jacques Puel	Rodez
France	Hôpital Delafontaine	Saint Denis
France	CHU Saint Etienne-Hôpital Nord	Saint Etienne
France	CH de Saint Malo	Saint Malo
France	CHU de Strasbourg - Hôpital de Hautepierre	Strasbourg
France	CHU de Strasbourg - Nouvel Hôpital Civil	Strasbourg
France	Hôpital Foch	Suresnes
France	CHU Tours	Tours

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France, University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		28 days
Secondary	Mortality rate		90 days
Secondary	Ventilator-associated pneumonia rate		until weaning of mechanical ventilation (average: 7 days)
Secondary	Nosocomial infections rate	Bloodstream infection Urinary tract infection Catheter-related infection Other infections	until discharge from ICU (average: 10 days)
Secondary	Length of stay in Intensive Care Unit (ICU)		until discharge from ICU (average: 10 days)
Secondary	Length of stay in hospital		until discharge from hospital (average: 17 days)
Secondary	Variations in Sepsis-related Organ Failure Assessment (SOFA) score		first week (7 days) of mechanical ventilation
Secondary	calories intake		until weaning of mechanical ventilation (average : 7 days)
Secondary	Proportion of patients given 100% of the calorie target		until weaning of mechanical ventilation (average: 7 days)
Secondary	cumulative calorie deficit from day 0 to day 7		During the first week (7 days) of mechanical ventilation
Secondary	Hospital mortality rate		Until discharge from hospital (average : 17 days)
Secondary	Intensive Care Unit (ICU) mortality rate		until discharge from ICU (average: 10 days)
Secondary	Acute bowel ischemia rate		until weaning of mechanical ventilation (average: 7 days)
Secondary	Vomiting rate		until weaning of mechanical ventilation (average: 7 days)