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

Launched by NANTES UNIVERSITY HOSPITAL · Aug 29, 2024

Keywords

ClinConnect Summary

The NUTRIREA-4 trial is studying whether a special rehabilitation program can help patients recover better after being on a ventilator and receiving medications for shock in the ICU. This program includes personalized nutrition, physiotherapy, and physical activities, starting early in the ICU and continuing at home after leaving the hospital. The goal is to see if this tailored approach leads to improved long-term health outcomes compared to the usual care that patients typically receive.

To participate in this trial, patients need to be 18 years or older, have started using a ventilator within the last 24 hours, and be receiving treatment for shock. They should also be able to give consent or have their family involved in the decision. Participants will either receive the early rehabilitation program or the standard care provided in their ICU. This trial is currently recruiting patients, and it aims to help improve recovery for those who have faced critical illnesses.

Gender

ALL

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