ClinicalTrials.gg
CompletedNCT01802099NUTRIREA2Updated Sep 4, 2026Results posted

Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines

An interventional study of Enteral nutrition and Parenteral nutrition in Acute Respiratory Failure and Shock, sponsored by Centre Hospitalier Departemental Vendee. Completed at 41 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

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

Phase
Not applicable
Study type
Interventional
Enrollment
2,410
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
3rd of 46
2,410 · median 139
Started
2013
with 2 others
No phase
32 of 107
6 open now
Registered
18th 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 3rd largest by enrollment of the 46 interventional ones that give a count, is one of 3 that started in 2013, is one of 32 with no phase, and was the 18th registered.

Shock

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

Browse Shock studies →

Open to participants now

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

19 more — sign in →

All 24 open studies →

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.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 107 studies in Shock with a site in France, or all of them as a file.
02

Study summary

The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.

03

Conditions studied

  • Acute Respiratory Failure
  • Shock

Keywords

  • mechanical ventilation
  • early enteral nutrition
  • intensive care unit
  • early parenteral nutrition
  • critical care medicine
  • nosocomial infection
  • mortality
  • shock
  • vasoactive drug
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
  • enteral nutrition via gastrostomy or jejunostomy
  • pregnancy
  • Treatment-limitation decisions
  • Current inclusion in a trial on comparison between enteral and parenteral nutrition
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
2,410 participants (actual)

Study arms

  • Other
    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

  • Other
    Enteral nutrition

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

    Other: Enteral nutrition

Interventions

  • OtherEnteral nutrition

    Also known as: Enteral feeding

  • OtherParenteral nutrition

    Also known as: Intravenous nutrition, intravenous feeding

06

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 28 days

Secondary outcomes

  1. Mortality Rate

    Time frame: 90 days

  2. Ventilator-associated Pneumonia Rate

    Time frame: until weaning of mechanical ventilation (average: 7 days)

  3. Nosocomial Infections Rate

    Bloodstream infection Urinary tract infection Catheter-related infection Other infections

    Time frame: until discharge from ICU (average: 10 days)

  4. Length of Stay in Intensive Care Unit (ICU)

    Time frame: until discharge from ICU (average: 10 days)

  5. Length of Stay in Hospital

    Time frame: until discharge from hospital (average: 17 days)

  6. Variations in Sepsis-related Organ Failure Assessment (SOFA) Score

    Time frame: first week (7 days) of mechanical ventilation

  7. Calories Intake

    Time frame: until weaning of mechanical ventilation (average : 7 days)

  8. Proportion of Patients Given 100% of the Calorie Target

    Time frame: until weaning of mechanical ventilation (average: 7 days)

  9. Cumulative Calorie Deficit From Day 0 to Day 7

    Time frame: During the first week (7 days) of mechanical ventilation

  10. Hospital Mortality Rate

    Time frame: Until discharge from hospital (average : 17 days)

  11. Intensive Care Unit (ICU) Mortality Rate

    Time frame: until discharge from ICU (average: 10 days)

  12. Acute Bowel Ischemia Rate

    Time frame: until weaning of mechanical ventilation (average: 7 days)

  13. Vomiting Rate

    Time frame: until weaning of mechanical ventilation (average: 7 days)

07

Results

Posted Jan 22, 2026

Participant flow

Participant flow — Overall Study
MilestoneParenteral NutritionEnteral Nutrition
Started12081202
Completed12081202
Not completed00

Outcome measures

PrimaryMortality
Time frame:
28 days
Reported as:
Count of participants · Participants
Mortality
ParticipantsParenteral NutritionEnteral Nutrition
Mortality422443
SecondaryMortality Rate
Time frame:
90 days
Reported as:
Count of participants · Participants
Mortality Rate
ParticipantsParenteral NutritionEnteral Nutrition
Mortality Rate507530
SecondaryVentilator-associated Pneumonia Rate
Time frame:
until weaning of mechanical ventilation (average: 7 days)

Results for this outcome have not been posted.

SecondaryNosocomial Infections Rate

Bloodstream infection Urinary tract infection Catheter-related infection Other infections

Time frame:
until discharge from ICU (average: 10 days)

Results for this outcome have not been posted.

SecondaryLength of Stay in Intensive Care Unit (ICU)
Time frame:
until discharge from ICU (average: 10 days)

Results for this outcome have not been posted.

SecondaryLength of Stay in Hospital
Time frame:
until discharge from hospital (average: 17 days)

Results for this outcome have not been posted.

SecondaryVariations in Sepsis-related Organ Failure Assessment (SOFA) Score
Time frame:
first week (7 days) of mechanical ventilation

Results for this outcome have not been posted.

SecondaryCalories Intake
Time frame:
until weaning of mechanical ventilation (average : 7 days)

Results for this outcome have not been posted.

SecondaryProportion of Patients Given 100% of the Calorie Target
Time frame:
until weaning of mechanical ventilation (average: 7 days)

Results for this outcome have not been posted.

SecondaryCumulative Calorie Deficit From Day 0 to Day 7
Time frame:
During the first week (7 days) of mechanical ventilation

Results for this outcome have not been posted.

SecondaryHospital Mortality Rate
Time frame:
Until discharge from hospital (average : 17 days)

Results for this outcome have not been posted.

SecondaryIntensive Care Unit (ICU) Mortality Rate
Time frame:
until discharge from ICU (average: 10 days)

Results for this outcome have not been posted.

SecondaryAcute Bowel Ischemia Rate
Time frame:
until weaning of mechanical ventilation (average: 7 days)

Results for this outcome have not been posted.

SecondaryVomiting Rate
Time frame:
until weaning of mechanical ventilation (average: 7 days)

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Parenteral Nutrition—0/1,208 (0%)0/1,208 (0%)
Enteral Nutrition—0/1,202 (0%)0/1,202 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Parenteral NutritionEnteral NutritionTotal
Mean66 ± 1466 ± 1466 ± 14
Sex: Female, Male
Sex: Female, Male(Participants)Parenteral NutritionEnteral NutritionTotal
Female8158091624
Male393393786
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Parenteral NutritionEnteral NutritionTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Parenteral NutritionEnteral NutritionTotal
France120812022410
08

Study locations

41 sites
  • CHU Amiens
    Amiens, 80054, France
  • CHU d'Angers
    Angers, 49933, France
  • Centre hospitalier d'Annecy
    Annecy, 74374, France
  • Centre Hospitalier de Beauvais
    Beauvais, 60021, France
  • CHU Besançon-Hôpital Jean Minjoz
    Besançon, 25000, France
  • CHU Pellegrin Tripode
    Bordeaux, 33076, France
  • CH Louis Pasteur
    Chartres, 28018, France
  • CHU Gabriel Montpied, Clermont Ferrand
    Clermont-Ferrand, 63003, France
  • CHU Louis Mourier
    Colombes, 92701, France
  • CH de Dieppe
    Dieppe, 76202, France
  • CHU Dijon
    Dijon, 21079, France
  • Hôpital Raymond Poincarre
    Garches, 92380, France
  • CHU Grenoble
    Grenoble, 38043, France
  • CHD Vendée - service de réanimation
    La Roche-sur-Yon, 85000, France
  • CHU de Bicêtre
    Le Kremlin-Bicêtre, 94275, France
  • CH Docteur Schaffner
    Lens, 62307, France
  • CHU Lille
    Lille, 59000, France
  • CHU de Lyon- Hôpital de la Croix Rousse
    Lyon, 69004, France
  • Hospices Civils de Lyon
    Lyon, 69437, France
  • CH Marc Jacquet
    Melun, 77000, France
  • CH de Montauban
    Montauban, 82013, France
  • CHI André Grégoire
    Montreuil, 93105, France
  • Hôpital Emile Muller
    Mulhouse, 68100, France
  • CHU de Nantes, Hopital Laennec
    Nantes, 44000, France
  • CHU de Nantes - Hôtel Dieu
    Nantes, 44093, France
  • Hôpital de La Source, CHR Orléans
    Orléans, 45067, France
  • CHU Saint Louis
    Paris, 75010, France
  • CHU Saint-Antoine
    Paris, 75012, France
  • CHU Paris Cochin
    Paris, 75014, France
  • Groupe Hospitalier Paris Saint Joseph
    Paris, 75014, France
  • Hôpital Tenon
    Paris, 75020, France
  • CHU Pointe à Pitre - Abymes
    Point À Pitre, 97110, France
  • CHU Poitiers
    Poitiers, 86021, France
  • Centre Hospitalier Jacques Puel
    Rodez, 12000, France
  • Hôpital Delafontaine
    Saint-Denis, 93200, France
  • CHU Saint Etienne-Hôpital Nord
    Saint-Etienne, 42055, France
  • CH de Saint Malo
    St-Malo, 35400, France
  • CHU de Strasbourg - Nouvel Hôpital Civil
    Strasbourg, 67091, France
  • CHU de Strasbourg - Hôpital de Hautepierre
    Strasbourg, 67098, France
  • Hôpital Foch
    Suresnes, 92150, France
  • CHU Tours
    Tours, 37044, France
09

References and documents

Publications

  • Brisard L, Le Gouge A, Lascarrou JB, Dupont H, Asfar P, Sirodot M, Piton G, Bui HN, Gontier O, Hssain AA, Gaudry S, Rigaud JP, Quenot JP, Maxime V, Schwebel C, Thevenin D, Nseir S, Parmentier E, El Kalioubie A, Jourdain M, Leray V, Rolin N, Bellec F, Das V, Ganster F, Guitton C, Asehnoune K, Bretagnol A, Anguel N, Mira JP, Canet E, Guidet B, Djibre M, Misset B, Robert R, Martino F, Letocart P, Silva D, Darmon M, Botoc V, Herbrecht JE, Meziani F, Devaquet J, Mercier E, Richecoeur J, Martin S, Greau E, Giraudeau B, Reignier J. Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2). Trials. 2014 Dec 23;15:507. doi: 10.1186/1745-6215-15-507. PubMed 25539571 ↗
  • Reignier J, Boisrame-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guerin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thevenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8. PubMed 29128300 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2013 to primary completion in Jul 2015, 28 months.

Results were first posted in Jan 2026, 10 years 6 months after primary completion.

Of 67 non-industry interventional studies with no phase under Shock, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 28 months is above that.

Counting every sponsor, half of 70 studies reached it within 25 months; a quarter within 8 and three quarters within 43.

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

Registered
Feb 27, 2013
First posted
Mar 1, 2013
StartActual
Mar 2013
Primary completionActual
Jul 2015
CompletionActual
Sep 2015
Results first posted
Jan 22, 2026
Last update
Sep 4, 2026
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 Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01802099
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Mar 1, 2013
Start date
Mar 2013
Primary completion
Jul 2015
Completion
Sep 2015
Results posted
Jan 22, 2026
Last update
Sep 4, 2026

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 completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion