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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-27

Study Completion Date

2015-07-07

Brief Summary

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

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Detailed Description

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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).

Conditions

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Acute Respiratory Failure Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Parenteral nutrition

Intervention Type OTHER

Enteral nutrition

Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.

Group Type ACTIVE_COMPARATOR

Enteral nutrition

Intervention Type OTHER

Interventions

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Parenteral nutrition

Intervention Type OTHER

Enteral nutrition

Intervention Type OTHER

Other Intervention Names

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Intravenous nutrition Intravenous feeding Enteral feeding

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No