Actively Recruiting
Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU
Led by Nantes University Hospital · Updated on 2026-01-23
830
Participants Needed
52
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The NUTRIREA-4 trial will test the hypothesis that an individually tailored rehabilitation program combining nutritional therapy, physiotherapy, and physical activity and started early in the ICU then continued uninterruptedly throughout the post-ICU stay and at home after hospital discharge improves the long-term outcomes of critical-illness survivors, compared to usual care. From ICU admission to recovery at home, the trial patients will receive either usual care or the early extended rehabilitation program. Usual care will consist in nutritional support and physiotherapy according to usual local practice in each participating ICU. The early extended program will consist of nutritional therapy, physiotherapy, and physical activity according to a standardized protocol tailored to general- and muscle-health improvements achieved in each individual patient over time.
CONDITIONS
Official Title
Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Invasive mechanical ventilation started in the ICU within the past 24 hours, or started before ICU admission with ICU admission within the past 24 hours, and expected to be required for at least 48 hours after randomization
- Treatment with a vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
- Nutritional support expected to be started within 24 hours after intubation or ICU admission
- Age 18 years or older
- Patient and/or next-of-kin informed about and consented to the trial
- Covered by the French public health-insurance system
You will not qualify if you...
- Mechanical ventilation started more than 24 hours earlier
- Specific nutritional needs such as long-term home enteral or parenteral nutrition for chronic bowel disease
- Dying patient, do-not-resuscitate order, or treatment-limitation decision at ICU admission
- Social circumstances hindering follow-up or telephone/video consultations
- Inability to provide a stable personal mobile phone number
- Communication difficulties via telephone or video consultation due to severe hearing or visual impairment
- Pre-existing chronic illness with life expectancy less than 6 months
- Pre-existing cognitive impairment
- Pre-existing spinal injury
- Inability to walk before the critical illness
- Acute or chronic neuromuscular disease
- Brain injury due to cardiac arrest, stroke, or severe trauma
- Pregnancy, recent delivery, or lactation
- Adult under guardianship
- Correctional facility inmate
- Institutionalized patient
- Prior inclusion in a randomized trial comparing rehabilitation programs during critical illness
AI-Screening
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Trial Site Locations
Total: 52 locations
1
CH d'Albi
Albi, France, 81013
Actively Recruiting
2
CHU d'Amiens - Site Sud
Amiens, France, 80054
Actively Recruiting
3
CHU d'Amiens
Amiens, France, 80054
Actively Recruiting
4
CHU d'Angers
Angers, France, 49933
Actively Recruiting
5
CH d'Angoulème
Angoulême, France, 16959
Actively Recruiting
6
CH d'Argenteuil
Argenteuil, France, 95100
Actively Recruiting
7
CH de Belfort
Belfort, France, 90015
Actively Recruiting
8
CHU de Besançon
Besançon, France, 25030
Actively Recruiting
9
CH de Béthune
Béthune, France, 62408
Actively Recruiting
10
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33000
Actively Recruiting
11
Centre Hospitalier William Morey
Chalon-sur-Saône, France, 71100
Actively Recruiting
12
CH de Cholet
Cholet, France, 49325
Actively Recruiting
13
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Actively Recruiting
14
CH de Dieppe
Dieppe, France, 76202
Actively Recruiting
15
CHU de Dijon
Dijon, France, 21079
Actively Recruiting
16
CH d'Annecy Genevois
Épagny, France, 74370
Actively Recruiting
17
Centre Hospitalier Sud Essonne
Étampes, France, 91150
Actively Recruiting
18
Hôpital Raymond Poincaré - AP-HP
Garches, France, 92380
Actively Recruiting
19
CHU de Grenoble
Grenoble, France, 38043
Actively Recruiting
20
CH d'Haguenau
Haguenau, France, 67504
Actively Recruiting
21
CH de Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
22
Hôpital de Bicêtre - AP-HP
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
23
CH du Mans
Le Mans, France, 72037
Actively Recruiting
24
CH de Lens
Lens, France, 62300
Actively Recruiting
25
CHRU de Lille
Lille, France, 59037
Actively Recruiting
26
CH de Lomme
Lomme, France, 59462
Actively Recruiting
27
CH de Lorient
Lorient, France, 56100
Actively Recruiting
28
CHU de Lyon
Lyon, France, 69437
Actively Recruiting
29
CHU de Montpellier
Montpellier, France, 34295
Actively Recruiting
30
CHU de Nantes
Nantes, France, 44000
Actively Recruiting
31
CHU de Nice - Hôpital Pasteur
Nice, France, 06100
Actively Recruiting
32
CHU de Nice
Nice, France, 06200
Actively Recruiting
33
CH d'Orléans
Orléans, France, 45100
Actively Recruiting
34
Hôpital Saint-Louis - AP-HP
Paris, France, 75010
Actively Recruiting
35
Hôpital Cochin - AP-HP
Paris, France, 75014
Actively Recruiting
36
Hôpital la Pitié-Salpétrière - AP-HP
Paris, France, 75651
Actively Recruiting
37
Hôpital Tenon - AP-HP
Paris, France, 75970
Actively Recruiting
38
CHU de Reims
Reims, France, 51092
Actively Recruiting
39
CHU de Rennes
Rennes, France, 35033
Actively Recruiting
40
CHU de Rouen
Rouen, France, 76000
Actively Recruiting
41
CH de Saint-Brieuc
Saint-Brieuc, France, 22027
Actively Recruiting
42
Hôpital Delafontaine
Saint-Denis, France, 93200
Actively Recruiting
43
Centre Hospitalier de Saint-Nazaire
Saint-Nazaire, France, 44600
Actively Recruiting
44
CHU de Saint-Etienne
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
45
CH de Saint-Malo
St-Malo, France, 35403
Actively Recruiting
46
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
Actively Recruiting
47
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67200
Actively Recruiting
48
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
49
CHU de Tours
Tours, France, 37044
Actively Recruiting
50
CH de Valenciennes
Valenciennes, France, 59322
Actively Recruiting
51
CH de Vannes
Vannes, France, 56017
Actively Recruiting
52
CH de Verdun
Verdun, France, 55100
Actively Recruiting
Research Team
D
Diane MAUGARS
CONTACT
C
Carole OUISSE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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