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

Last updated: May 12, 2025
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Control group

Rehabilitation group

Clinical Study ID

NCT06581939
RC23_0585
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Invasive mechanical ventilation (MV) started in the ICU within the past 24 h, orstarted before ICU admission with ICU admission within the past 24 h, and expectedto be required for at least 48 hours after randomization

  • Treatment with a vasoactive agent for shock (adrenaline, dobutamine, ornoradrenaline)

  • Nutritional support expected to be started within 24 h after intubation (or within 24 h after ICU admission if intubation occurred before ICU admission)

  • Age 18 or older

  • Patient and/or next-of-kin informed about the trial and having consented toparticipation in the trial. If the patient is unable to receive information and nonext-of-kin can be contacted during screening for the trial, trial inclusion will becompleted as an emergency procedure by the ICU physician, in compliance with Frenchlaw.

  • Covered by the French public health-insurance system

Exclusion

Exclusion Criteria:

  • MV started more than 24 hours earlier

  • Specific nutritional needs, such as pre-existing long-term home enteral orparenteral nutrition for chronic bowel disease

  • Dying patient, do-not-resuscitate order, or other treatment- limitation decision atICU admission

  • Social circumstances hindering follow-up and telephone/video consultations (no fixedaddress, non-European residence)

  • Inability to provide a stable personal mobile phone number (temporary number or notin the owner's name)

  • Communication difficulties via telephone or video consultation (pre-existing severehearing or visual impairment)

  • Pre-existing chronic illness with life expectancy <6 months

  • Pre-existing cognitive impairment

  • Pre-existing spinal injury

  • Inability to walk before the critical illness

  • Acute or chronic neuromuscular disease

  • Brain injury, e.g., 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 designed to compare rehabilitation programsdelivered to patients during critical illness

Study Design

Total Participants: 830
Treatment Group(s): 2
Primary Treatment: Control group
Phase:
Study Start date:
December 14, 2024
Estimated Completion Date:
December 14, 2027

Connect with a study center

  • CH d'Albi

    Albi, 81013
    France

    Active - Recruiting

  • CHU d'Amiens

    Amiens, 80054
    France

    Active - Recruiting

  • CHU d'Amiens - Site Sud

    Amiens, 80054
    France

    Active - Recruiting

  • CHU d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • CH d'Angoulème

    Angoulême, 16959
    France

    Active - Recruiting

  • CH d'Argenteuil

    Argenteuil, 95100
    France

    Active - Recruiting

  • CH de Belfort

    Belfort, 90015
    France

    Active - Recruiting

  • CHU de Besançon

    Besançon, 25030
    France

    Active - Recruiting

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000
    France

    Active - Recruiting

  • CH de Béthune

    Béthune, 62408
    France

    Active - Recruiting

  • CH de Cholet

    Cholet, 49325
    France

    Active - Recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • CH de Dieppe

    Dieppe, 76202
    France

    Active - Recruiting

  • CHU de Dijon

    Dijon, 21079
    France

    Active - Recruiting

  • Hôpital Raymond Poincaré - AP-HP

    Garches, 92380
    France

    Active - Recruiting

  • CHU de Grenoble

    Grenoble, 38043
    France

    Active - Recruiting

  • CH d'Haguenau

    Haguenau, 67504
    France

    Active - Recruiting

  • CH de Vendée

    La Roche-sur-Yon, 85925
    France

    Active - Recruiting

  • Hôpital de Bicêtre - AP-HP

    Le Kremlin-Bicêtre, 94275
    France

    Active - Recruiting

  • CH du Mans

    Le Mans, 72037
    France

    Active - Recruiting

  • CH de Lens

    Lens, 62300
    France

    Active - Recruiting

  • CHRU de Lille

    Lille, 59037
    France

    Active - Recruiting

  • CH de Lomme

    Lomme, 59462
    France

    Active - Recruiting

  • CH de Lorient

    Lorient, 56100
    France

    Active - Recruiting

  • CHU de Lyon

    Lyon, 69437
    France

    Active - Recruiting

  • CH de Melun

    Melun, 77000
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier, 34295
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • CHU de Nice

    Nice, 06200
    France

    Active - Recruiting

  • CHU de Nice - Hôpital Pasteur

    Nice, 06100
    France

    Active - Recruiting

  • CH d'Orléans

    Orléans, 45100
    France

    Active - Recruiting

  • Hôpital Cochin - AP-HP

    Paris, 75014
    France

    Active - Recruiting

  • Hôpital Saint-Louis - AP-HP

    Paris, 75010
    France

    Active - Recruiting

  • Hôpital Tenon - AP-HP

    Paris, 75970
    France

    Active - Recruiting

  • Hôpital la Pitié-Salpétrière - AP-HP

    Paris, 75651
    France

    Active - Recruiting

  • CHU de Reims

    Reims, 51092
    France

    Active - Recruiting

  • CHU de Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • CHU de Rouen

    Rouen, 76000
    France

    Active - Recruiting

  • CH de Saint-Brieuc

    Saint-Brieuc, 22027
    France

    Active - Recruiting

  • Hôpital Delafontaine

    Saint-Denis, 93200
    France

    Active - Recruiting

  • CH de Saint-Malo

    Saint-Malo, 35403
    France

    Active - Recruiting

  • CHU de Saint-Etienne

    Saint-Priest-en-Jarez, 42270
    France

    Active - Recruiting

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200
    France

    Active - Recruiting

  • CHU de Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091
    France

    Active - Recruiting

  • Hôpital Foch

    Suresnes, 92150
    France

    Active - Recruiting

  • CH de Bigorre

    Tarbes, 65000
    France

    Active - Recruiting

  • CHU de Tours

    Tours, 37044
    France

    Active - Recruiting

  • CH de Valenciennes

    Valenciennes, 59322
    France

    Active - Recruiting

  • CH de Vannes

    Vannes, 56017
    France

    Active - Recruiting

  • CH de Verdun

    Verdun, 55100
    France

    Active - Recruiting

  • CH d'Annecy Genevois

    Épagny, 74370
    France

    Active - Recruiting

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