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Clinical Trials in France / NCT06581939
Recruiting Not applicable

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

NCT06581939 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-12-14
Last updated
2026-01-23

Condition(s) studied

Mechanical Ventilation

Investigational drug(s) / intervention(s)

Rehabilitation groupControl group

Rehabilitation group: In the rehabilitation group, patients will follow an individualized rehabilitation program started early in the ICU and continued in the post-ICU ward then at home for 12 weeks, combining goal-directed nutrition and physical activity, tailored to gains made over time by each patient, with the involvement of dieticians, physiotherapists, and adapted-physical-activity instructors.

Control group: In the control group, patients will receive usual care from day-0 to day-180.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Invasive mechanical ventilation (MV) started in the ICU within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, 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 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 to participation in the trial. If the patient is unable to receive information and no next-of-kin can be contacted during screening for the trial, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law. * Covered by the French public health-insurance system Exclusion Criteria: * MV started more than 24 hours earlier * Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition for chronic bowel disease * Dying patient, do-not-resuscitate order, or other treatment- limitation decision at ICU admission * Social circumstances hindering follow-up and telephone/video consultations (no fixed address, non-European residence) * Inability to provide a stable personal mobile phone number (temporary number or not in the owner's name) * Communication difficulties via telephone or video consultation (pre-existing severe hearing 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 programs delivered to patients during critical illness

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
CH d'Albi Albi France Recruiting
CHU d'Amiens - Site Sud Amiens France Recruiting
CHU d'Amiens Amiens France Recruiting
CHU d'Angers Angers France Recruiting
CH d'Angoulème Angoulême France Recruiting
CH d'Argenteuil Argenteuil France Recruiting
CH de Belfort Belfort France Recruiting
CHU de Besançon Besançon France Recruiting
CH de Béthune Béthune France Recruiting
CHU de Bordeaux - Hôpital Pellegrin Bordeaux France Recruiting
Centre Hospitalier William Morey Chalon-sur-Saône France Recruiting
CH de Cholet Cholet France Recruiting
CHU de Clermont-Ferrand Clermont-Ferrand France Recruiting
CH de Dieppe Dieppe France Recruiting
CHU de Dijon Dijon France Recruiting
CH d'Annecy Genevois Épagny France Recruiting
Centre Hospitalier Sud Essonne Étampes France Recruiting
Hôpital Raymond Poincaré - AP-HP Garches France Recruiting
CHU de Grenoble Grenoble France Recruiting
CH d'Haguenau Haguenau France Recruiting
CH de Vendée La Roche-sur-Yon France Recruiting
Hôpital de Bicêtre - AP-HP Le Kremlin-Bicêtre France Recruiting
CH du Mans Le Mans France Recruiting
CH de Lens Lens France Recruiting
CHRU de Lille Lille France Recruiting
CH de Lomme Lomme France Recruiting
CH de Lorient Lorient France Recruiting
CHU de Lyon Lyon France Recruiting
CHU de Montpellier Montpellier France Recruiting
CHU de Nantes Nantes France Recruiting
CHU de Nice - Hôpital Pasteur Nice France Recruiting
CHU de Nice Nice France Recruiting
CH d'Orléans Orléans France Recruiting
Hôpital Saint-Louis - AP-HP Paris France Recruiting
Hôpital Cochin - AP-HP Paris France Recruiting
Hôpital la Pitié-Salpétrière - AP-HP Paris France Recruiting
Hôpital Tenon - AP-HP Paris France Recruiting
CHU de Reims Reims France Recruiting
CHU de Rennes Rennes France Recruiting
CHU de Rouen Rouen France Recruiting

+ 12 more sites — see the full list on the official registry below.

More Nantes University Hospital trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06581939 on ClinicalTrials.gov ↗ ← All trials in France