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)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03411447

Enrollment

139

Registered

2018-01-26

Start date

2015-01-27

Completion date

2015-07-07

Last updated

2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Shock

Keywords

vasoactive drug, mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality, shock

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).

Interventions

OTHERParenteral nutrition

OTHEREnteral nutrition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026