Mechanical Ventilation
Conditions
Keywords
Critical care, Nutritional support, Mechanical ventilation, Shock, Macronutrients, Rehabilitation, Physiotherapy, Adapted physical activity
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.
Interventions
PROCEDURERehabilitation 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.
PROCEDUREControl group
In the control group, patients will receive usual care from day-0 to day-180.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | 6 months after randomization | Handgrip strength (Kg and percent of predicted strength) at 6 months after randomization |
| Medical Research Council (MRC) score | 6 months after randomization | MRC score at 6 months after randomization |
| Muscle mass assessed by the mid-arm muscle circumference (MAMC) | 6 months after randomization | MAMC at 6 months after randomization |
| Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) | 3 months after randomization | IPAQ-SF score at 3 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 | 6 months | Mean changes in body weight measured at 6 months) |
| Mortality rates | Day 90 | 90-day 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) |
Countries
France
Contacts
CONTACTDiane MAUGARS
CONTACTCarole OUISSE
PRINCIPAL_INVESTIGATORJean REIGNIER, MD, PhD
Nantes University Hospital
Outcome results
None listed