Clinical trial NCT06581939: 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
Official title: 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 : A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Ventilation
Keywords: Critical care
Nutritional support
Mechanical ventilation
Shock
Macronutrients
Rehabilitation
Physiotherapy
Adapted physical activity
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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 outcomes:
measure: 6-minute-walk distance
timeFrame: 6 months
Secondary outcomes:
measure: Handgrip strength
timeFrame: 6 months after randomization
measure: Medical Research Council (MRC) score
timeFrame: 6 months after randomization
measure: Muscle mass assessed by the mid-arm muscle circumference (MAMC)
timeFrame: 6 months after randomization
measure: Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: 3 months after randomization
measure: Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: 4 months after randomization
measure: Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: 5 months after randomization
measure: Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: 6 months after randomization
measure: Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: 12 months after randomization
measure: Calorie intakes
timeFrame: From day 0 to 12 months
measure: Protein intakes
timeFrame: From day 0 to 12 months
measure: Body weight
timeFrame: 6 months
measure: Mortality rates
timeFrame: Day 90
measure: Mortality rates
timeFrame: 6 months
measure: Mortality rates
timeFrame: 12 months
measure: Hypoglycemia
timeFrame: From day 0 to day 7
measure: Blood glucose
timeFrame: From day 0 to day 7
measure: Quality of life assessed using the Short Form 36 Health Survey (SF-36)
timeFrame: 6 and 12 months
measure: Handgrip strength
timeFrame: ICU discharge, an average of 10 days
measure: Handgrip strength
timeFrame: Hospital discharge, an average of 20 days
measure: Medical Research Council (MRC) score
timeFrame: ICU discharge, an average of 10 days
measure: Medical Research Council (MRC) score
timeFrame: Hospital discharge, an average of 20 days
measure: Muscle mass assessed by the mid-arm muscle circumference (MAMC)
timeFrame: ICU discharge, an average of 10 days
measure: Muscle mass assessed by the mid-arm muscle circumference (MAMC)
timeFrame: Hospital discharge, an average of 20 days
measure: Body weight
timeFrame: ICU discharge, an average of 10 days
measure: Mortality rates
timeFrame: ICU discharge, an average of 10 days
measure: Mechanical Ventilation (MV) duration
timeFrame: From D0 until the date of cessation of mechanical ventilation, an average of 7 days
measure: ICU-acquired infection
timeFrame: From day 0 until the date of discharge from ICU, an average of 10 days
measure: ICU and hospital stay lengths
timeFrame: From day 0 until the day of discharge from hospital, an average of 20 days
measure: Mortality rates
timeFrame: Hospital discharge, an average of 20 days
measure: Insulin
timeFrame: From day 0 until the date of ICU discharge, an average of 10 days
measure: Delay from randomization to first standing-up
timeFrame: From date of randomization until the date of first standing-up, an average of 7 days
measure: Delay from randomization to first walking
timeFrame: From date of randomization until the date of first walking, an average of 15 days
Other outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 and 12 months
measure: Post-traumatic stress disorder Check List for DSM-5 (PCL-5)
timeFrame: 6 and 12 months
measure: Resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC10)
timeFrame: 6 and 12 months
measure: Posttraumatic growth using the Posttraumatic Growth Inventory Short Form (PTGI-SF)
timeFrame: 6 and 12 months
measure: Cognitive performance using the Montreal Cognitive Assessment (MoCA)
timeFrame: 6 and 12 months
Locations:
city: Albi
country: France
facility: CH d'Albi
city: Amiens
country: France
facility: CHU d'Amiens - Site Sud
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Angoulême
country: France
facility: CH d'Angoulème
city: Argenteuil
country: France
facility: CH d'Argenteuil
city: Belfort
country: France
facility: CH de Belfort
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Béthune
country: France
facility: CH de Béthune
city: Cholet
country: France
facility: CH de Cholet
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Dieppe
country: France
facility: CH de Dieppe
city: Dijon
country: France
facility: CHU de Dijon
city: Garches
country: France
facility: Hôpital Raymond Poincaré - AP-HP
city: Grenoble
country: France
facility: CHU de Grenoble
city: Haguenau
country: France
facility: CH d'Haguenau
city: La Roche-sur-Yon
country: France
facility: CH de Vendée
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital de Bicêtre - AP-HP
city: Le Mans
country: France
facility: CH du Mans
city: Lens
country: France
facility: CH de Lens
city: Lille
country: France
facility: CHRU de Lille
city: Lomme
country: France
facility: CH de Lomme
city: Lorient
country: France
facility: CH de Lorient
city: Lyon
country: France
facility: CHU de Lyon
city: Melun
country: France
facility: CH de Melun
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice - Hôpital Pasteur
city: Nice
country: France
facility: CHU de Nice
city: Orléans
country: France
facility: CH d'Orléans
city: Paris
country: France
facility: Hôpital Saint-Louis - AP-HP
city: Paris
country: France
facility: Hôpital Cochin - AP-HP
city: Paris
country: France
facility: Hôpital la Pitié-Salpétrière - AP-HP
city: Paris
country: France
facility: Hôpital Tenon - AP-HP
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Brieuc
country: France
facility: CH de Saint-Brieuc
city: Saint-Denis
country: France
facility: Hôpital Delafontaine
city: Saint-Malo
country: France
facility: CH de Saint-Malo
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg - Nouvel Hôpital Civil
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital de Hautepierre
city: Suresnes
country: France
facility: Hôpital Foch
city: Tarbes
country: France
facility: CH de Bigorre
city: Tours
country: France
facility: CHU de Tours
city: Valenciennes
country: France
facility: CH de Valenciennes
city: Vannes
country: France
facility: CH de Vannes
city: Verdun
country: France
facility: CH de Verdun
city: Épagny
country: France
facility: CH d'Annecy Genevois
Study officials:
affiliation: Nantes University Hospital
name: Jean REIGNIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: