Status:
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
Lead Sponsor:
Nantes University Hospital
Conditions:
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2027
Estimated Enrollment :
830 Patients enrolled
Trial Details
Trial ID
NCT06581939
Start Date
December 14 2024
End Date
December 14 2027
Last Update
May 15 2025
Active Locations (51)
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1
CH d'Albi
Albi, France, 81013
2
CHU d'Amiens - Site Sud
Amiens, France, 80054
3
CHU d'Amiens
Amiens, France, 80054
4
CHU d'Angers
Angers, France, 49933