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New treatment option for Mechanical Ventilation
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
ClinicalTrials.gov ID: NCT06581939
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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)
See the full eligibility 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...
- 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 assigned by chance trial designed to compare rehabilitation programs delivered to patients during critical illness
The study team makes the final eligibility decision.
Where it's taking place
- Albi, France
- Amiens, France
- Angers, France
- Angoulême, France
- Argenteuil, France
- Belfort, France
- Besançon, France
- Béthune, France
- Bordeaux, France
- Chalon-sur-Saône, France
- Cholet, France
- Clermont-Ferrand, France
- Dieppe, France
- Dijon, France
- Épagny, France
- Étampes, France
- Garches, France
- Grenoble, France
- Haguenau, France
- La Roche-sur-Yon, France
+ 26 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albi, France; Amiens, France; Angers, France; Angoulême, France; Argenteuil, France; Belfort, France and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.