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

Not Applicable

Terminated

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

• Registration Number: NCT03411447
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief Summary

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

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 Timeline

• Study Start: 2015-01-27
• Primary Completion: 2015-07-07
• Study Completion: 2015-07-07
• Study First Submitted: 2017-07-18
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-25
• Study First Posted: 2018-01-26
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 139

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

Secondary Outcome Measures

Name	Time	Method
Salivary amylase levels in tracheal aspirates.	48Hours following randomisation	Every tracheal aspirate will be collected during 48hours following randomisation. Salivary amylase will be analysed.

Trial Locations

Locations (6)

CHU Louis Mourier; 🇫🇷 Colombes, France

Centre hospitalier d'Annecy; 🇫🇷 Annecy, France

CHU Lille; 🇫🇷 Lille, France

CHU Amiens; 🇫🇷 Amiens, France

CHU Saint Louis; 🇫🇷 Paris, France

CHU Tours; 🇫🇷 Tours, France