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Clinical Trial NCT06581939 (NUTRIREA-4) for Mechanical Ventilation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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 (NUTRIREA-4)
Clinical Trial NCT06581939 (NUTRIREA-4) is an interventional study for Mechanical Ventilation that is recruiting. It started on 14 December 2024 with plans to enroll 830 participants. Led by Nantes University Hospital, it is expected to complete by 14 December 2027. The latest data from ClinicalTrials.gov was last updated on 15 May 2025.
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.
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
Conditions
Mechanical VentilationOther Study IDs
- NUTRIREA-4
- RC23_0585
NCT ID Number
Start Date (Actual)
2024-12-14
Last Update Posted
2025-05-15
Completion Date (Estimated)
2027-12-14
Enrollment (Estimated)
830
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Critical care
Nutritional support
Mechanical ventilation
Shock
Macronutrients
Rehabilitation
Physiotherapy
Adapted physical activity
Nutritional support
Mechanical ventilation
Shock
Macronutrients
Rehabilitation
Physiotherapy
Adapted physical activity
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRehabilitation group Individualized rehabilitation program | 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. |
Active ComparatorControl group Usual care | Control Group In the control group, patients will receive usual care from day-0 to day-180. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
6-minute-walk distance | 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. | 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Handgrip strength | Handgrip strength (Kg and percent of predicted strength) at 6 months after randomization | 6 months after randomization |
Medical Research Council (MRC) score | MRC score at 6 months after randomization | 6 months after randomization |
Muscle mass assessed by the mid-arm muscle circumference (MAMC) | MAMC at 6 months after randomization | 6 months after randomization |
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) | IPAQ-SF score at 3 months after randomization | 3 months after randomization |
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) | IPAQ-SF score at 4 months after randomization | 4 months after randomization |
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) | IPAQ-SF score at 5 months after randomization | 5 months after randomization |
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) | IPAQ-SF score at 6 months after randomization | 6 months after randomization |
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) | IPAQ-SF score at 12 months after randomization | 12 months after randomization |
Calorie intakes | Calorie intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization) | From day 0 to 12 months |
Protein intakes | Protein intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization) | From day 0 to 12 months |
Body weight | Mean changes in body weight measured at 6 months) | 6 months |
Mortality rates | 90-day mortality rates | Day 90 |
Mortality rates | 6-month mortality rates | 6 months |
Mortality rates | 12-months mortality rates | 12 months |
Hypoglycemia | Proportion of patients with at least one hypoglycemia from day 0 to day 7 | From day 0 to day 7 |
Blood glucose | Mean blood glucose from day 0 to day 7 | From day 0 to day 7 |
Quality of life assessed using the Short Form 36 Health Survey (SF-36) | SF-36 scores 6 and 12 months after randomization | 6 and 12 months |
Handgrip strength | Handgrip strength (Kg and percent of predicted strength) at ICU discharge | ICU discharge, an average of 10 days |
Handgrip strength | Handgrip strength (Kg and percent of predicted strength) at hospital discharge | Hospital discharge, an average of 20 days |
Medical Research Council (MRC) score | MRC score at ICU discharge | ICU discharge, an average of 10 days |
Medical Research Council (MRC) score | MRC score at hospital discharge | Hospital discharge, an average of 20 days |
Muscle mass assessed by the mid-arm muscle circumference (MAMC) | MAMC at ICU discharge | ICU discharge, an average of 10 days |
Muscle mass assessed by the mid-arm muscle circumference (MAMC) | MAMC at hospital discharge | Hospital discharge, an average of 20 days |
Body weight | Mean changes in body weight measured at ICU discharge | ICU discharge, an average of 10 days |
Mortality rates | ICU discharge mortality rates | ICU discharge, an average of 10 days |
Mechanical Ventilation (MV) duration | Days of MV | From D0 until the date of cessation of mechanical ventilation, an average of 7 days |
ICU-acquired infection | Proportion of patients with at least one ICU-acquired infection | From day 0 until the date of discharge from ICU, an average of 10 days |
ICU and hospital stay lengths | ICU and hospital stay lengths (days) | From day 0 until the day of discharge from hospital, an average of 20 days |
Mortality rates | Hospital discharge mortality rates | Hospital discharge, an average of 20 days |
Insulin | Days on insulin in the ICU | From day 0 until the date of ICU discharge, an average of 10 days |
Delay from randomization to first standing-up | Delay from randomization to first standing-up (days) | From date of randomization until the date of first standing-up, an average of 7 days |
Delay from randomization to first walking | Delay from randomization to first walking (days) | From date of randomization until the date of first walking, an average of 15 days |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
Nantes University HospitalStudy Central Contact
Contact: Diane MAUGARS, +33(0)253482473, [email protected]
Contact: Carole OUISSE, +33(0)244768205, [email protected]
51 Study Locations in 1 Countries
CHU de Bordeaux - Hôpital Pellegrin, Bordeaux, 33000, France
Vivien GUILLOTIN, Contact, [email protected]
Recruiting
CHU de Clermont-Ferrand, Clermont-Ferrand, 63003, France
Bertrand SOUWEINE, Contact, [email protected]
Recruiting
Hôpital Raymond Poincaré - AP-HP, Garches, 92380, France
Virginie MAXIME, Contact, [email protected]
Recruiting
CHU de Grenoble, Grenoble, 38043, France
Louis-Marie GALERNEAU, Contact, [email protected]
Recruiting
CH de Vendée, La Roche-sur-Yon, 85925, France
Isabelle VINATIER, Contact, [email protected]
Recruiting
Hôpital de Bicêtre - AP-HP, Le Kremlin-Bicêtre, 94275, France
Laurent GUERIN, Contact, [email protected]
Recruiting
CHU de Nantes, Nantes, 44000, France
Jean REIGNIER, MD, Contact, 0240087361, [email protected]
Recruiting
CHU de Nice - Hôpital Pasteur, Nice, 06100, France
Matthieu BOIFFIER, Contact, [email protected]
Recruiting
Hôpital Saint-Louis - AP-HP, Paris, 75010, France
Michael DARMON, Contact, [email protected]
Recruiting
Hôpital la Pitié-Salpétrière - AP-HP, Paris, 75651, France
Elise MORAWIEC, Contact, [email protected]
Recruiting
CH de Saint-Brieuc, Saint-Brieuc, 22027, France
Mattieu DEBARRE, Contact, [email protected]
Recruiting
CHU de Saint-Etienne, Saint-Priest-en-Jarez, 42270, France
Guillaume THIERY, Contact, [email protected]
Recruiting
CHU de Strasbourg - Nouvel Hôpital Civil, Strasbourg, 67091, France
Hamid MERDJI, Contact, [email protected]
Recruiting
CHU de Strasbourg - Hôpital de Hautepierre, Strasbourg, 67200, France
Jean-Etienne HERBRECHT, Contact, [email protected]
Recruiting
CH de Valenciennes, Valenciennes, 59322, France
Fabien LAMBIOTTE, Contact, [email protected]
Recruiting