NCT03411447

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

July 18, 2017

Last Update Submit

January 25, 2018

Conditions

Acute Respiratory FailureShock

Keywords

vasoactive drugmechanical ventilationearly enteral nutritionintensive care unitearly parenteral nutritioncritical care medicinenosocomial infectionmortalityshock

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Salivary amylase levels in tracheal aspirates.

    48Hours following randomisation

Study Arms (2)

Parenteral nutrition

ACTIVE COMPARATOR

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

Enteral nutrition

ACTIVE COMPARATOR

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

Other: Enteral nutrition

Interventions

Parenteral nutritionOTHER
Also known as: Intravenous nutrition, Intravenous feeding
Parenteral nutrition
Enteral nutritionOTHER
Also known as: Enteral feeding
Enteral nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of esophageal, gastric, duodenal or pancreatic surgery
  • Bleeding from the esophagus, stomach or bowel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Amiens

Amiens, 80054, France

Location

Centre hospitalier d'Annecy

Annecy, 74374, France

Location

CHU Louis Mourier

Colombes, France

Location

CHU Lille

Lille, 59000, France

Location

CHU Saint Louis

Paris, 75010, France

Location

CHU Tours

Tours, 37044, France

Location

Related Publications (1)

  • 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.

    PMID: 30953553DERIVED

MeSH Terms

Conditions

ShockHyperphagiaCross Infection

Interventions

Parenteral NutritionEnteral Nutrition

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsInfectionsIatrogenic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Jean REIGNIER, MD, PhD

    CHD Vendee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

January 26, 2018

Study Start

January 27, 2015

Primary Completion

July 7, 2015

Study Completion

July 7, 2015

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

FR(6)