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

• ClinicalTrials.gov Identifier: NCT01802099
• Recruitment Status: Terminated
• First Posted: March 1, 2013
• Last Update Posted: February 25, 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
• Information provided by (Responsible Party): Centre Hospitalier Departemental Vendee

Tracking Information

• First Submitted Date: February 27, 2013
• First Posted Date: March 1, 2013
• Last Update Posted Date: February 25, 2019
• Study Start Date: March 2013
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 28, 2013): Mortality [ Time Frame: 28 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 28, 2013)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Acute Respiratory Failure
• Shock

Intervention

• Other: Enteral nutrition
  Other Name: Enteral feeding
• Other: Parenteral nutrition
  Other Names:

  • Intravenous nutrition
  • intravenous feeding

Study Arms

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

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 25, 2016): 2411
• Original Estimated Enrollment (submitted: February 28, 2013): 2854
• Actual Study Completion Date: September 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01802099
• Other Study ID Numbers: CHD085-11
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Centre Hospitalier Departemental Vendee
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Departemental Vendee
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Centre Hospitalier Departemental Vendee
• Verification Date: February 2019