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

Acute Respiratory Failure Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03411447
• Other study ID #: CHD085-13
• Status: Terminated
• Phase: N/A
• First received: July 18, 2017
• Last updated: January 25, 2018
• Start date: January 27, 2015
• Est. completion date: July 7, 2015

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 139
• Est. completion date: July 7, 2015
• Est. primary completion date: July 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Aspiration of Gastric Contents
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Shock

Intervention

Other:
• Parenteral nutrition

• Enteral nutrition

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	Centre hospitalier d'Annecy	Annecy
France	CHU Louis Mourier	Colombes
France	CHU Lille	Lille
France	CHU Saint Louis	Paris
France	CHU Tours	Tours

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France, University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

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