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

Not Applicable

Terminated

• Conditions: Shock; Acute Respiratory Failure
• Interventions: Other: Parenteral nutrition; Other: Enteral nutrition

• Registration Number: NCT01802099
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-28
• Study Start: 2013-03
• Study First Posted: 2013-03-01
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2411

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parenteral nutrition	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.
Enteral nutrition	Enteral nutrition	Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.

Primary Outcome Measures

Name	Time	Method
Mortality	28 days

Secondary Outcome Measures

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

Trial Locations

Locations (41)

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hôpital Emile Muller; 🇫🇷 Mulhouse, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHU Saint Etienne-Hôpital Nord; 🇫🇷 Saint Etienne, France

CH Louis Pasteur; 🇫🇷 Chartres, France

CHU de Strasbourg - Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

CHU Tours; 🇫🇷 Tours, France

Centre Hospitalier de Beauvais; 🇫🇷 Beauvais, France

CH de Dieppe; 🇫🇷 Dieppe, France

Hôpital Delafontaine; 🇫🇷 Saint Denis, France

Hôpital Raymond Poincarre; 🇫🇷 Garches, France

CHU de Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

CHU de Lyon- Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

CHD Vendée - service de réanimation; 🇫🇷 La Roche sur Yon, France

CHU Paris Cochin; 🇫🇷 Paris, France

CHU Amiens; 🇫🇷 Amiens, France

CHI André Grégoire; 🇫🇷 Montreuil, France

Centre Hospitalier Jacques Puel; 🇫🇷 Rodez, France

CHU d'Angers; 🇫🇷 Angers, France

CHU Lille; 🇫🇷 Lille, France

CHU Saint-Antoine; 🇫🇷 Paris, France

CHU Saint Louis; 🇫🇷 Paris, France

CH de Saint Malo; 🇫🇷 Saint Malo, France

CH de Montauban; 🇫🇷 Montauban, France

CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

CHU Besançon-Hôpital Jean Minjoz; 🇫🇷 Besançon, France

CHU Pointe à Pitre - Abymes; 🇫🇷 Pointe À Pitre, France

CH Marc Jacquet; 🇫🇷 Melun, France

Hôpital de La Source, CHR Orléans; 🇫🇷 Orléans, France

Centre hospitalier d'Annecy; 🇫🇷 Annecy, France

CHU de Strasbourg - Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France

Hôpital Tenon; 🇫🇷 Paris, France

Hôpital Foch; 🇫🇷 Suresnes, France

Groupe Hospitalier Paris Saint Joseph; 🇫🇷 Paris, France

CHU Pellegrin Tripode; 🇫🇷 Bordeaux, France

CHU Louis Mourier; 🇫🇷 Colombes, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU de Nantes, Hopital Laennec; 🇫🇷 Nantes, France

CHU Gabriel Montpied, Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

CHU Dijon; 🇫🇷 Dijon, France

CH Docteur Schaffner; 🇫🇷 Lens, France