Rehabilitation program for ICU patients on mechanical ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The NUTRIREA-4 trial aims to evaluate the effectiveness of a tailored rehabilitation program that combines nutritional therapy, physiotherapy, and physical activity for patients who have undergone invasive mechanical ventilation and vasopressor therapy in the ICU. Participants will be randomly assigned to receive either the early extended rehabilitation program or usual care, with the goal of improving long-term outcomes for critically ill survivors. The program will begin in the ICU and continue through the post-ICU recovery phase and at home after discharge. This approach seeks to enhance both general and muscle health in patients recovering from critical illness.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Jean REIGNIER, MD, PhD — Nantes University Hospital
• Study coordinator: Diane MAUGARS
• Email: diane.maugars@chu-nantes.fr
• Phone: +33(0)253482473

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.