Acute Respiratory FailureNUTRIREA2NCT01802099
Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines
A study testing Enteral nutrition and Parenteral nutrition in people with Acute Respiratory Failure and Shock, run by Centre Hospitalier Departemental Vendee at 41 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Shock
- What is being tested?
- Enteral nutrition and Parenteral nutrition
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,410 participants
- Where
- 41 sitesFrance
- Study dates
- Mar 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
France41 sites
CHU Amiens
Amiens, 80054
CHU d'Angers
Angers, 49933
Centre hospitalier d'Annecy
Annecy, 74374
Centre Hospitalier de Beauvais
Beauvais, 60021
CHU Besançon-Hôpital Jean Minjoz
Besançon, 25000
CHU Pellegrin Tripode
Bordeaux, 33076
CH Louis Pasteur
Chartres, 28018
CHU Gabriel Montpied, Clermont Ferrand
Clermont-Ferrand, 63003
CHU Louis Mourier
Colombes, 92701
CH de Dieppe
Dieppe, 76202
CHU Dijon
Dijon, 21079
Hôpital Raymond Poincarre
Garches, 92380
CHU Grenoble
Grenoble, 38043
CHD Vendée - service de réanimation
La Roche-sur-Yon, 85000
CHU de Bicêtre
Le Kremlin-Bicêtre, 94275
CH Docteur Schaffner
Lens, 62307
CHU Lille
Lille, 59000
CHU de Lyon- Hôpital de la Croix Rousse
Lyon, 69004
Hospices Civils de Lyon
Lyon, 69437
CH Marc Jacquet
Melun, 77000
CH de Montauban
Montauban, 82013
CHI André Grégoire
Montreuil, 93105
Hôpital Emile Muller
Mulhouse, 68100
CHU de Nantes, Hopital Laennec
Nantes, 44000
CHU de Nantes - Hôtel Dieu
Nantes, 44093
Hôpital de La Source, CHR Orléans
Orléans, 45067
CHU Saint Louis
Paris, 75010
CHU Saint-Antoine
Paris, 75012
CHU Paris Cochin
Paris, 75014
Groupe Hospitalier Paris Saint Joseph
Paris, 75014
Hôpital Tenon
Paris, 75020
CHU Pointe à Pitre - Abymes
Point À Pitre, 97110
CHU Poitiers
Poitiers, 86021
Centre Hospitalier Jacques Puel
Rodez, 12000
Hôpital Delafontaine
Saint-Denis, 93200
CHU Saint Etienne-Hôpital Nord
Saint-Etienne, 42055
CH de Saint Malo
St-Malo, 35400
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67091
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
Hôpital Foch
Suresnes, 92150
CHU Tours
Tours, 37044
About this study
Official title: Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines: Multicenter, Randomized Controlled Trial (NUTRIREA-2)
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.
- Conditions
- Acute Respiratory Failure, Shock
- Being tested
- Enteral nutrition, Parenteral nutrition
- Keywords
- mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality, shock, vasoactive drug
- Medical subject headings
- Shock, Hyperphagia, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutritionOther
Also called Enteral feeding
Parenteral nutritionOther
Also called Intravenous nutrition, intravenous feeding
| Study group | Role | What they receive |
|---|---|---|
| Parenteral nutrition | Other | 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. Receives: Other: Parenteral nutrition |
| Enteral nutrition | Other | Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. Receives: Other: Enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 28 days
Secondary outcomes (13)
Mortality Rate
Measured: 90 days
Ventilator-associated Pneumonia Rate
Measured: until weaning of mechanical ventilation (average: 7 days)
Nosocomial Infections Rate
Bloodstream infection Urinary tract infection Catheter-related infection Other infections
Measured: until discharge from ICU (average: 10 days)
Length of Stay in Intensive Care Unit (ICU)
Measured: until discharge from ICU (average: 10 days)
Length of Stay in Hospital
Measured: until discharge from hospital (average: 17 days)
Variations in Sepsis-related Organ Failure Assessment (SOFA) Score
Measured: first week (7 days) of mechanical ventilation
Calories Intake
Measured: until weaning of mechanical ventilation (average : 7 days)
Proportion of Patients Given 100% of the Calorie Target
Measured: until weaning of mechanical ventilation (average: 7 days)
Cumulative Calorie Deficit From Day 0 to Day 7
Measured: During the first week (7 days) of mechanical ventilation
Hospital Mortality Rate
Measured: Until discharge from hospital (average : 17 days)
Intensive Care Unit (ICU) Mortality Rate
Measured: until discharge from ICU (average: 10 days)
Acute Bowel Ischemia Rate
Measured: until weaning of mechanical ventilation (average: 7 days)
Vomiting Rate
Measured: until weaning of mechanical ventilation (average: 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 2,410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Jean Reignier, MD, PhD, Principal investigator, CHD Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802099
- Sponsor's protocol ID
- CHD085-11
- Acronym
- NUTRIREA2
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2013
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 25539571Reignier 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 at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines: Multicenter, Randomized Controlled Trial (NUTRIREA-2)
- ClinicalTrials.gov ID
- NCT01802099
- Acronym / sponsor ID
- NUTRIREA2 / CHD085-11
- Conditions
- Acute Respiratory Failure, Shock
- Keywords
- mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality, shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,410 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours
- Study start
- Mar 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition | Other | Other: Parenteral nutritionPatients 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. |
| Enteral nutrition | Other | Other: Enteral nutritionPatients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral nutritionAlso: Enteral feeding | Other | Enteral nutrition |
| Parenteral nutritionAlso: Intravenous nutrition, intravenous feeding | Other | Parenteral nutrition |
Primary outcome
Mortality
Time frame: 28 days
13 secondary outcomes
Mortality Rate
Time frame: 90 days
Ventilator-associated Pneumonia Rate
Time frame: until weaning of mechanical ventilation (average: 7 days)
Nosocomial Infections Rate
Time frame: until discharge from ICU (average: 10 days)
Length of Stay in Intensive Care Unit (ICU)
Time frame: until discharge from ICU (average: 10 days)
Length of Stay in Hospital
Time frame: until discharge from hospital (average: 17 days)
Variations in Sepsis-related Organ Failure Assessment (SOFA) Score
Time frame: first week (7 days) of mechanical ventilation
Calories Intake
Time frame: until weaning of mechanical ventilation (average : 7 days)
Proportion of Patients Given 100% of the Calorie Target
Time frame: until weaning of mechanical ventilation (average: 7 days)
Cumulative Calorie Deficit From Day 0 to Day 7
Time frame: During the first week (7 days) of mechanical ventilation
Hospital Mortality Rate
Time frame: Until discharge from hospital (average : 17 days)
Intensive Care Unit (ICU) Mortality Rate
Time frame: until discharge from ICU (average: 10 days)
Acute Bowel Ischemia Rate
Time frame: until weaning of mechanical ventilation (average: 7 days)
Vomiting Rate
Time frame: until weaning of mechanical ventilation (average: 7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25539571Brisard 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.
- Results publication: PubMed 29128300Reignier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Reignier, MD, PhD principal investigator
CHD Vendee
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral nutrition and Parenteral nutrition in people with Acute Respiratory Failure and Shock, run by Centre Hospitalier Departemental Vendee at 41 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01802099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.