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Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.

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

Author information

1
Médecine Intensive Réanimation, CHU de Nantes, Nantes, France; Université de Nantes, Nantes, France. Electronic address: jean.reignier@chu-nantes.fr.
2
EA 7293, Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg, Strasbourg, France; Medical Intensive Care Unit, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
3
CHU de Nantes, Hôpital Laennec, Département d'Anesthésie et Réanimation, Nantes, France.
4
Médecine Intensive Réanimation, CHU de Nantes, Nantes, France; Université de Nantes, Nantes, France.
5
Medical Intensive Care Unit, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand, France.
6
Medical Intensive Care Unit, CHU de Bicêtre, Assistance Publique-Hôpitaux de Paris (AP-HP), Le Kremlin-Bicêtre, France.
7
Medical Intensive Care Unit, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.
8
Surgical Intensive Care Unit, Hotel Dieu, CHU de Nantes, Nantes, France; Université de Nantes, Nantes, France.
9
Medical Intensive Care and Hyperbaric Oxygen Therapy Unit, Centre Hospitalier Universitaire Angers, Angers, France; Laboratoire de Biologie Neurovasculaire et Mitochondriale Intégrée, CNRS UMR 6214 - INSERM U1083, Université Angers, UBL, Angers, France.
10
Medical-Surgical Intensive Care Unit, Centre Hospitalier de Montauban, Montauban, France.
11
Medical-Surgical Intensive Care Unit, Centre Hospitalier de Saint-Malo, Saint-Malo, France.
12
Medical Intensive Care Unit, CHR Orléans, Orléans, France.
13
Medical Intensive Care Unit, Hôpital Pellegrin, CHU Bordeaux, Bordeaux, France.
14
Medical Intensive Care Unit, Saint Louis University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
15
Medical-Surgical Intensive Care Unit, Centre Hospitalier de Saint-Denis, Saint-Denis, France.
16
Medical-Surgical Intensive Care Unit, University Hospital, Saint Etienne, France.
17
Medical-Surgical Intensive Care Unit, Centre Hospitalier Intercommunal André Grégoire, Montreuil, France.
18
Medical-Surgical Intensive Care Unit, Hôpital Foch, Suresnes, France.
19
Medical-Surgical Intensive Care Unit, Tenon University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
20
Medical Intensive Care Unit, Hôpital Emile Muller, Mulhouse, France.
21
UMR 1137, IAME Team 5, Decision Sciences in Infectious Diseases (DeSCID), Control and Care, Sorbonne Paris Cité, Inserm-Paris Diderot University, Paris, France; Medical-Surgical Unit, Hôpital Saint-Joseph, Paris France; Medical Unit and Palliative Research Group, French and British Institute, Levallois-Perret, France; OUTCOMEREA Research Group, Drancy, France.
22
Medical-Surgical Intensive Care Unit, Hôpital Louis Mourier, Assistance Publique-Hôpitaux de Paris (AP-HP), Colombes, France; Université Paris Diderot, ECEVE, UMR 1123, Sorbonne Paris Cité, Paris, France.
23
Medical-Surgical Intensive Care Unit, Hôpital de Chartres, Chartres, France.
24
Medical Intensive Care Unit, Groupement Hospitalier Nord, Hospices Civils de Lyon, Lyon, France; Université de Lyon, IMRB INSERM 955, Lyon, France.
25
Medical Intensive Care Unit, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France; Sorbonne Université, UPMC Université Paris 06, INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe: Epidémiologie Hospitalière Qualité et Organisation des Soins, Paris, France.
26
Medical-Surgical Intensive Care Unit, Hôpital du Mans, Le Mans, France.
27
Medical Intensive Care Unit, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, Strasbourg, France; Faculté de Médecine U1121, Université de Strasbourg, Fédération de Médecine Translationnelle de Strasbourg (FMTS), Strasbourg, France.
28
Médecine Intensive Réanimation, Centre Hospitalier Départemental de la Vendée, La Roche sur Yon, France.
29
Medical-Surgical Intensive Care Unit, Hôpital Jacques Puel, Rodez, France.
30
Medical-Surgical Intensive Care Unit, CHU de Pointe-à-Pitre, Pointe-à-Pitre, France.
31
Medical-Surgical Intensive Care Unit, Hôpital Raymond Poincaré, Assistance Publique-Hôpitaux de Paris (AP-HP), Garches, France.
32
Médecine Intensive Réanimation, Hôpital Bretonneau, CHU Tours, Tours, France.
33
Medical Intensive Care Unit, Cochin University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
34
Medical Intensive Care Unit, CHU Lille, Lille, France; Université Lille, Medicine School, Lille, France.
35
Medical Intensive Care Unit, CHRU Besançon, Besançon, France; EA3920, Université de Franche Comté, Besançon, France.
36
Medical-Surgical Intensive Care Unit, François Mitterrand University Hospital, Dijon, France; Lipness Team, INSERM UMR 866 and LabExLipSTIC, Université de Bourgogne, Dijon, France.
37
Medical-Surgical Intensive Care Unit, Hôpital de Beauvais, Beauvais, France.
38
Medical-Surgical Intensive Care Unit, Hôpital de Dieppe, Dieppe, France.
39
Medical Intensive Care Unit, CHU Poitiers, Poitiers, France; Université de Poitiers, INSERM CIC1402, Poitiers, France.
40
Medical-Surgical Intensive Care Unit, Centre Hospitalier de Melun, Melun, France.
41
Medical Intensive Care Unit, CHU Albert Michallon Grenoble, Grenoble, France; Inserm U1039, Radiopharmaceutiques Biocliniques, Université Grenoble Alpes, La Tronche, France.
42
Medical-Surgical Intensive Care Unit, Centre Hospitalier Annecy-Genevois, Metz-Tessy, Pringy, France.
43
Surgical Intensive Care Unit, CHU Amiens Picardie, Amiens, France.
44
Medical-Surgical Intensive Care Unit, Centre Hospitalier Docteur Schaffner, Lens, France.
45
Inserm CIC 1415, Tours, France; Université de Tours, Tours, France; CHU Tours, Tours, France; Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France.
46
Inserm CIC 1415, Tours, France; Université de Tours, Tours, France; CHU Tours, Tours, France.

Abstract

BACKGROUND:

Whether the route of early feeding affects outcomes of patients with severe critical illnesses is controversial. We hypothesised that outcomes were better with early first-line enteral nutrition than with early first-line parenteral nutrition.

METHODS:

In this randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2 trial) done at 44 French intensive-care units (ICUs), adults (18 years or older) receiving invasive mechanical ventilation and vasopressor support for shock were randomly assigned (1:1) to either parenteral nutrition or enteral nutrition, both targeting normocaloric goals (20-25 kcal/kg per day), within 24 h after intubation. Randomisation was stratified by centre using permutation blocks of variable sizes. Given that route of nutrition cannot be masked, blinding of the physicians and nurses was not feasible. Patients receiving parenteral nutrition could be switched to enteral nutrition after at least 72 h in the event of shock resolution (no vasopressor support for 24 consecutive hours and arterial lactate <2 mmol/L). The primary endpoint was mortality on day 28 after randomisation in the intention-to-treat-population. This study is registered with ClinicalTrials.gov, number NCT01802099.

FINDINGS:

After the second interim analysis, the independent Data Safety and Monitoring Board deemed that completing patient enrolment was unlikely to significantly change the results of the trial and recommended stopping patient recruitment. Between March 22, 2013, and June 30, 2015, 2410 patients were enrolled and randomly assigned; 1202 to the enteral group and 1208 to the parenteral group. By day 28, 443 (37%) of 1202 patients in the enteral group and 422 (35%) of 1208 patients in the parenteral group had died (absolute difference estimate 2·0%; [95% CI -1·9 to 5·8]; p=0·33). Cumulative incidence of patients with ICU-acquired infections did not differ between the enteral group (173 [14%]) and the parenteral group (194 [16%]; hazard ratio [HR] 0·89 [95% CI 0·72-1·09]; p=0·25). Compared with the parenteral group, the enteral group had higher cumulative incidences of patients with vomiting (406 [34%] vs 246 [20%]; HR 1·89 [1·62-2·20]; p<0·0001), diarrhoea (432 [36%] vs 393 [33%]; 1·20 [1·05-1·37]; p=0·009), bowel ischaemia (19 [2%] vs five [<1%]; 3·84 [1·43-10·3]; p=0·007), and acute colonic pseudo-obstruction (11 [1%] vs three [<1%]; 3·7 [1·03-13·2; p=0·04).

INTERPRETATION:

In critically ill adults with shock, early isocaloric enteral nutrition did not reduce mortality or the risk of secondary infections but was associated with a greater risk of digestive complications compared with early isocaloric parenteral nutrition.

FUNDING:

La Roche-sur-Yon Departmental Hospital and French Ministry of Health.

PMID:
29128300
DOI:
10.1016/S0140-6736(17)32146-3
[Indexed for MEDLINE]

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