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

Conditions

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

Brief 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.

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, Djibré M, Thevenin D, Pasco J, Balduyck M, Zerimech F, Reignier J.

2019-04-0513 citations

10.1186/s13054-019-2403-z

Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2).

Reignier J, Boisramé-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, Guérin 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, Thévenin D, Giraudeau B, Le Gouge A, NUTRIREA-2 Trial Investigators, Clinical Research in Intensive Care and Sepsis (CRICS) group.

2017-11-08362 citations

10.1016/s0140-6736(17)32146-3

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).

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, Thévenin 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, Gréau E, Giraudeau B, Reignier J.

2014-12-237 citations

10.1186/1745-6215-15-507

Interventions

OTHEREnteral nutrition

OTHERParenteral nutrition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Mortality	28 days

Secondary

Measure	Time frame	Description
Acute Bowel Ischemia Rate	until weaning of mechanical ventilation (average: 7 days)	—
Vomiting Rate	until weaning of mechanical ventilation (average: 7 days)	—
Mortality Rate	90 days	—
Ventilator-associated Pneumonia Rate	until weaning of mechanical ventilation (average: 7 days)	—
Nosocomial Infections Rate	until discharge from ICU (average: 10 days)	Bloodstream infection Urinary tract infection Catheter-related infection Other infections
Length of Stay in Intensive Care Unit (ICU)	until discharge from ICU (average: 10 days)	—
Length of Stay in Hospital	until discharge from hospital (average: 17 days)	—
Variations in Sepsis-related Organ Failure Assessment (SOFA) Score	first week (7 days) of mechanical ventilation	—
Calories Intake	until weaning of mechanical ventilation (average : 7 days)	—
Proportion of Patients Given 100% of the Calorie Target	until weaning of mechanical ventilation (average: 7 days)	—
Cumulative Calorie Deficit From Day 0 to Day 7	During the first week (7 days) of mechanical ventilation	—
Intensive Care Unit (ICU) Mortality Rate	until discharge from ICU (average: 10 days)	—
Hospital Mortality Rate	Until discharge from hospital (average : 17 days)	—

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean Reignier, MD, PhD

CHD Vendee

Baseline characteristics

Characteristic	—
Age, Continuous	66 years STANDARD_DEVIATION 14
Race and Ethnicity Not Collected	0 Participants
Region of Enrollment France	1202 participants
Sex: Female, Male Female	1624 Participants
Sex: Female, Male Male	393 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
other Total, other adverse events	0 / 1,208	0 / 1,202
serious Total, serious adverse events	0 / 1,208	0 / 1,202

Outcome results

None listed