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
- Conditions
- Mechanical Ventilation
- Registration Number
- NCT06581939
- Lead Sponsor
- Nantes University Hospital
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 830
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 6-minute-walk distance 6 months The primary endpoint is the 6-minute-walk distance (6MWD), in meters, assessed by blinded physicians and research nurses during a hospital visit 6 months after randomization.
- Secondary Outcome Measures
Name Time Method Handgrip strength Hospital discharge, an average of 20 days Handgrip strength (Kg and percent of predicted strength) at hospital discharge
Medical Research Council (MRC) score Hospital discharge, an average of 20 days MRC score at hospital discharge
Muscle mass assessed by the mid-arm muscle circumference (MAMC) Hospital discharge, an average of 20 days MAMC at hospital discharge
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) 12 months after randomization IPAQ-SF score at 12 months after randomization
Calorie intakes From day 0 to 12 months Calorie intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)
Protein intakes From day 0 to 12 months Protein intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)
Body weight ICU discharge, an average of 10 days Mean changes in body weight measured at ICU discharge
Mortality rates Hospital discharge, an average of 20 days Hospital discharge mortality rates
Hypoglycemia From day 0 to day 7 Proportion of patients with at least one hypoglycemia from day 0 to day 7
Blood glucose From day 0 to day 7 Mean blood glucose from day 0 to day 7
Quality of life assessed using the Short Form 36 Health Survey (SF-36) 6 and 12 months SF-36 scores 6 and 12 months after randomization
Mechanical Ventilation (MV) duration From D0 until the date of cessation of mechanical ventilation, an average of 7 days Days of MV
ICU-acquired infection From day 0 until the date of discharge from ICU, an average of 10 days Proportion of patients with at least one ICU-acquired infection
ICU and hospital stay lengths From day 0 until the day of discharge from hospital, an average of 20 days ICU and hospital stay lengths (days)
Insulin From day 0 until the date of ICU discharge, an average of 10 days Days on insulin in the ICU
Delay from randomization to first standing-up From date of randomization until the date of first standing-up, an average of 7 days Delay from randomization to first standing-up (days)
Delay from randomization to first walking From date of randomization until the date of first walking, an average of 15 days Delay from randomization to first walking (days)
Trial Locations
- Locations (51)
CH d'Haguenau
🇫🇷Haguenau, France
CHU de Rennes
🇫🇷Rennes, France
CH d'Albi
🇫🇷Albi, France
CHU d'Amiens - Site Sud
🇫🇷Amiens, France
CHU d'Amiens
🇫🇷Amiens, France
CHU d'Angers
🇫🇷Angers, France
CH d'Angoulème
🇫🇷Angoulême, France
CH d'Argenteuil
🇫🇷Argenteuil, France
CH de Belfort
🇫🇷Belfort, France
CHU de Besançon
🇫🇷Besançon, France
CHU de Bordeaux - Hôpital Pellegrin
🇫🇷Bordeaux, France
CH de Béthune
🇫🇷Béthune, France
CH de Cholet
🇫🇷Cholet, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CH de Dieppe
🇫🇷Dieppe, France
CHU de Dijon
🇫🇷Dijon, France
Hôpital Raymond Poincaré - AP-HP
🇫🇷Garches, France
CHU de Grenoble
🇫🇷Grenoble, France
CH de Vendée
🇫🇷La Roche-sur-Yon, France
Hôpital de Bicêtre - AP-HP
🇫🇷Le Kremlin-Bicêtre, France
CH du Mans
🇫🇷Le Mans, France
CH de Lens
🇫🇷Lens, France
CHRU de Lille
🇫🇷Lille, France
CH de Lomme
🇫🇷Lomme, France
CH de Lorient
🇫🇷Lorient, France
CHU de Lyon
🇫🇷Lyon, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU de Nantes
🇫🇷Nantes, France
CH de Melun
🇫🇷Melun, France
CHU de Nice - Hôpital Pasteur
🇫🇷Nice, France
CH d'Orléans
🇫🇷Orléans, France
Hôpital Cochin - AP-HP
🇫🇷Paris, France
CHU de Saint-Etienne
🇫🇷Saint-Priest-en-Jarez, France
CHU de Nice
🇫🇷Nice, France
Hôpital Tenon - AP-HP
🇫🇷Paris, France
CHU de Reims
🇫🇷Reims, France
CHU de Rouen
🇫🇷Rouen, France
Hôpital Saint-Louis - AP-HP
🇫🇷Paris, France
Hôpital la Pitié-Salpétrière - AP-HP
🇫🇷Paris, France
CH de Saint-Brieuc
🇫🇷Saint-Brieuc, France
CHU de Strasbourg - Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Hôpital Delafontaine
🇫🇷Saint-Denis, France
Hôpital Foch
🇫🇷Suresnes, France
CH de Bigorre
🇫🇷Tarbes, France
CHU de Tours
🇫🇷Tours, France
CH de Valenciennes
🇫🇷Valenciennes, France
CH de Saint-Malo
🇫🇷Saint-Malo, France
CHU de Strasbourg - Hôpital de Hautepierre
🇫🇷Strasbourg, France
CH de Vannes
🇫🇷Vannes, France
CH de Verdun
🇫🇷Verdun, France
CH d'Annecy Genevois
🇫🇷Épagny, France