Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines

Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)

To evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions

Study Overview

• Status: Terminated
• Conditions: Shock; Acute Respiratory Failure
• Intervention / Treatment: Other: Parenteral nutrition; Other: Enteral nutrition

Detailed Description

A common obstacle to enteral nutrition is gastrointestinal intolerance, with regurgitations potentially responsible for gastric-content aspiration. Several studies involving technetium 99m (99mTc) labeling of gastric contents have established that gastric-fluid microaspiration is common in critically ill patients receiving both endotracheal ventilation and enteral nutrition. However, to our knowledge, no studies have specifically addressed the role for enteral nutrition in the occurrence of microaspiration. The objective of this ancillary study is to compare the frequency of gastric-content microaspiration in patients given enteral versus parenteral nutrition during the NUTRIREA2 trial. The new knowledge of risk factors for microaspiration provided by this study may help to improve strategies for preventing microaspiration and ventilator-associated pneumonia (VAP).

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens
  • Annecy, France, 74374
    • Centre Hospitalier d'Annecy
  • Colombes, France
    • CHU Louis Mourier
  • Lille, France, 59000
    • CHU Lille
  • Paris, France, 75010
    • CHU Saint Louis
  • Tours, France, 37044
    • Chu Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Parenteral nutrition; Other Names: Intravenous nutrition; Intravenous feeding
Active Comparator: Enteral nutrition; Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.	Other: Enteral nutrition; Other Names: Enteral feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients with abundant microaspiration (defined as a pepsin level >200 ng/mL in at least 30% of tracheal aspirates)	Every tracheal aspirate will be collected during 48hours following randomisation	48Hours following randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary amylase levels in tracheal aspirates.	Every tracheal aspirate will be collected during 48hours following randomisation. Salivary amylase will be analysed.	48Hours following randomisation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Ministry of Health, France; University Hospital, Tours

Publications and helpful links

General Publications

• Nseir S, Le Gouge A, Lascarrou JB, Lacherade JC, Jaillette E, Mira JP, Mercier E, Declercq PL, Sirodot M, Piton G, Tinturier F, Coupez E, Gaudry S, Djibre M, Thevenin D, Pasco J, Balduyck M, Zerimech F, Reignier J. Impact of nutrition route on microaspiration in critically ill patients with shock: a planned ancillary study of the NUTRIREA-2 trial. Crit Care. 2019 Apr 5;23(1):111. doi: 10.1186/s13054-019-2403-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2015
• Primary Completion (Actual): July 7, 2015
• Study Completion (Actual): July 7, 2015

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: intensive care unit; mechanical ventilation; shock; mortality; early parenteral nutrition; nosocomial infection; critical care medicine; vasoactive drug; early enteral nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Respiratory Aspiration; Respiratory Insufficiency; Respiratory Aspiration of Gastric Contents
• Other Study ID Numbers: CHD085-13