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

NCT ID: NCT01802099

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Failure Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Parenteral nutrition

Intervention Type OTHER

Enteral nutrition

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

Group Type OTHER

Enteral nutrition

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enteral nutrition

Intervention Type OTHER

Parenteral nutrition

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Enteral feeding Intravenous nutrition intravenous feeding

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* enteral nutrition via gastrostomy or jejunostomy
* pregnancy
* Treatment-limitation decisions
* Current inclusion in a trial on comparison between enteral and parenteral nutrition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role collaborator

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean Reignier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHD Vendee

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Amiens

Amiens, , France

Site Status

CHU d'Angers

Angers, , France

Site Status

Centre hospitalier d'Annecy

Annecy, , France

Site Status

Centre Hospitalier de Beauvais

Beauvais, , France

Site Status

CHU Besançon-Hôpital Jean Minjoz

Besançon, , France

Site Status

CHU Pellegrin Tripode

Bordeaux, , France

Site Status

CH Louis Pasteur

Chartres, , France

Site Status

CHU Gabriel Montpied, Clermont Ferrand

Clermont-Ferrand, , France

Site Status

CHU Louis Mourier

Colombes, , France

Site Status

CH de Dieppe

Dieppe, , France

Site Status

CHU Dijon

Dijon, , France

Site Status

Hôpital Raymond Poincarre

Garches, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

CHD Vendée - service de réanimation

La Roche-sur-Yon, , France

Site Status

CHU de Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

CH Docteur Schaffner

Lens, , France

Site Status

CHU Lille

Lille, , France

Site Status

CHU de Lyon- Hôpital de la Croix Rousse

Lyon, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

CH Marc Jacquet

Melun, , France

Site Status

CH de Montauban

Montauban, , France

Site Status

CHI André Grégoire

Montreuil, , France

Site Status

Hôpital Emile Muller

Mulhouse, , France

Site Status

CHU de Nantes, Hopital Laennec

Nantes, , France

Site Status

CHU de Nantes - Hôtel Dieu

Nantes, , France

Site Status

Hôpital de La Source, CHR Orléans

Orléans, , France

Site Status

CHU Saint Louis

Paris, , France

Site Status

CHU Saint-Antoine

Paris, , France

Site Status

CHU Paris Cochin

Paris, , France

Site Status

Groupe Hospitalier Paris Saint Joseph

Paris, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

CHU Pointe à Pitre - Abymes

Pointe à Pitre, , France

Site Status

CHU Poitiers

Poitiers, , France

Site Status

Centre Hospitalier Jacques Puel

Rodez, , France

Site Status

Hôpital Delafontaine

Saint-Denis, , France

Site Status

CHU Saint Etienne-Hôpital Nord

Saint-Etienne, , France

Site Status

CH de Saint Malo

St-Malo, , France

Site Status

CHU de Strasbourg - Nouvel Hôpital Civil

Strasbourg, , France

Site Status

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

CHU Tours

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29128300 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25539571 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHD085-11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.