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: December 16, 2024
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

    Site Not Available

  • CHU d'Amiens

    Amiens, 80054
    France

    Site Not Available

  • CHU d'Amiens - Site Sud

    Amiens, 80054
    France

    Site Not Available

  • CHU d'Angers

    Angers, 49933
    France

    Site Not Available

  • CH d'Angoulème

    Angoulême, 16959
    France

    Site Not Available

  • CH d'Argenteuil

    Argenteuil, 95100
    France

    Site Not Available

  • CH de Belfort

    Belfort, 90015
    France

    Site Not Available

  • CHU de Besançon

    Besançon, 25030
    France

    Site Not Available

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000
    France

    Site Not Available

  • CH de Béthune

    Béthune, 62408
    France

    Site Not Available

  • CH de Cholet

    Cholet, 49325
    France

    Site Not Available

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003
    France

    Site Not Available

  • CH de Dieppe

    Dieppe, 76202
    France

    Site Not Available

  • CHU de Dijon

    Dijon, 21079
    France

    Site Not Available

  • Hôpital Raymond Poincaré - AP-HP

    Garches, 92380
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble, 38043
    France

    Site Not Available

  • CH d'Haguenau

    Haguenau, 67504
    France

    Site Not Available

  • CH de Vendée

    La Roche-sur-Yon, 85925
    France

    Site Not Available

  • Hôpital de Bicêtre - AP-HP

    Le Kremlin-Bicêtre, 94275
    France

    Site Not Available

  • CH du Mans

    Le Mans, 72037
    France

    Site Not Available

  • CH de Lens

    Lens, 62300
    France

    Site Not Available

  • CHRU de Lille

    Lille, 59037
    France

    Site Not Available

  • CH de Lomme

    Lomme, 59462
    France

    Site Not Available

  • CH de Lorient

    Lorient, 56100
    France

    Site Not Available

  • CHU de Lyon

    Lyon, 69437
    France

    Site Not Available

  • CH de Melun

    Melun, 77000
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • CHU de Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • CHU de Nice

    Nice, 06200
    France

    Site Not Available

  • CHU de Nice - Hôpital Pasteur

    Nice, 06100
    France

    Site Not Available

  • CH d'Orléans

    Orléans, 45100
    France

    Site Not Available

  • Hôpital Cochin - AP-HP

    Paris, 75014
    France

    Site Not Available

  • Hôpital Saint-Louis - AP-HP

    Paris, 75010
    France

    Site Not Available

  • Hôpital Tenon - AP-HP

    Paris, 75970
    France

    Site Not Available

  • Hôpital la Pitié-Salpétrière - AP-HP

    Paris, 75651
    France

    Site Not Available

  • CHU de Reims

    Reims, 51092
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35033
    France

    Site Not Available

  • CHU de Rouen

    Rouen, 76000
    France

    Site Not Available

  • CH de Saint-Brieuc

    Saint-Brieuc, 22027
    France

    Site Not Available

  • Hôpital Delafontaine

    Saint-Denis, 93200
    France

    Site Not Available

  • CH de Saint-Malo

    Saint-Malo, 35403
    France

    Site Not Available

  • CHU de Saint-Etienne

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200
    France

    Site Not Available

  • CHU de Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091
    France

    Site Not Available

  • Hôpital Foch

    Suresnes, 92150
    France

    Site Not Available

  • CH de Bigorre

    Tarbes, 65000
    France

    Site Not Available

  • CHU de Tours

    Tours, 37044
    France

    Site Not Available

  • CH de Valenciennes

    Valenciennes, 59322
    France

    Site Not Available

  • CH de Vannes

    Vannes, 56017
    France

    Site Not Available

  • CH de Verdun

    Verdun, 55100
    France

    Site Not Available

  • CH d'Annecy Genevois

    Épagny, 74370
    France

    Site Not Available

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