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
NotablePrimary completion pushed from Jun 14, 2027 to Dec 14, 2027
Study completion pushed from Dec 14, 2027 to Jun 14, 2028
Eligibility criteria expanded, about 23 words
Site details revised at 11 of 52 sites
MinorStudy sites: 51 to 52v6
MinorSite details revised at 50 of 51 sitesv5
NotableTrial status: Not Yet Recruiting to Recruitingv4Show 4 more changesShow less
Primary completion date: Jun 1, 2027 to Jun 14, 2027
Study completion date: Dec 1, 2027 to Dec 14, 2027
Start date changed from estimate of Dec 1, 2024 to Dec 14, 2024
Site details revised at 51 of 51 sites
MinorSecondary endpoints: 37 to 32v3
NotableStart date: Oct 1, 2024 to Dec 1, 2024
Study sites: 50 to 51
Primary completion date: Apr 1, 2027 to Jun 1, 2027
Study completion date: Oct 1, 2027 to Dec 1, 2027
v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.