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TerminatedNCT03411447Updated Jan 26, 2018

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

An interventional study of Parenteral nutrition and Enteral nutrition in Acute Respiratory Failure and Shock, sponsored by Centre Hospitalier Departemental Vendee. Terminated at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-26.

Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Prevention

Why this study was terminated
stopped on Data Safety and Monitoring Board 's request

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jan 2015, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 107 studies in Shock with a site in France — 24 open to participants now, 27 under way, 1 of them phase 3. Shock · France.

Enrollment
23rd of 46
139 · median 139
Started
2015
with 6 others
No phase
32 of 107
6 open now
Registered
37th of 107
by date
Lead sponsor
3 of 107
Centre Hospitalier Departemental Vendee

Among the 107 studies in Shock with a site in France, this one is the 23rd largest by enrollment of the 46 interventional ones that give a count, is one of 7 that started in 2015, is one of 32 with no phase, and was the 37th registered.

Shock

487 studies on the registry are indexed under Shock; 107 are open to participants now.

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Open to participants now

24 of the 107 studies in Shock with a site in France are open now. Recruiting first, the newest first:

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A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 68 Shock studies recruiting now, 52 (76%) set no upper age limit and 11 (16%) stop at 75 or younger; 9 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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).

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Abdominal surgery within 1 month before inclusion
  • History of esophageal, gastric, duodenal or pancreatic surgery
  • Bleeding from the esophagus, stomach or bowel
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
139 participants (actual)

Study arms

  • Active comparator
    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.

    Other: Parenteral nutrition

  • Active comparator
    Enteral nutrition

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

    Other: Enteral nutrition

Interventions

  • OtherParenteral nutrition

    Also known as: Intravenous nutrition, Intravenous feeding

  • OtherEnteral nutrition

    Also known as: Enteral feeding

06

What researchers measure

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

    Time frame: 48Hours following randomisation

Secondary outcomes

  1. Salivary amylase levels in tracheal aspirates.

    Every tracheal aspirate will be collected during 48hours following randomisation. Salivary amylase will be analysed.

    Time frame: 48Hours following randomisation

07

Study locations

6 sites
  • CHU Amiens
    Amiens, 80054, France
  • Centre hospitalier d'Annecy
    Annecy, 74374, France
  • CHU Louis Mourier
    Colombes, France
  • CHU Lille
    Lille, 59000, France
  • CHU Saint Louis
    Paris, 75010, France
  • CHU Tours
    Tours, 37044, France
08

References and documents

Publications

  • 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. PubMed 30953553 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2015 to primary completion in Jul 2015, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2017
First posted
Jan 26, 2018
StartActual
Jan 27, 2015
Primary completionActual
Jul 7, 2015
CompletionActual
Jul 7, 2015
Last update
Jan 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03411447
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Jan 26, 2018
Start date
Jan 27, 2015
Primary completion
Jul 7, 2015
Completion
Jul 7, 2015
Last update
Jan 26, 2018

Study contacts

Jean REIGNIER, MD, PhD
principal investigator · CHD Vendee

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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