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RecruitingNCT07329530

Metabolic and Muscle Profile in ICU Survivors

Characterisation of the Inflammatory, Metabolic, and Mitochondrial Profiles in the Context of Post-Intensive Care Muscle Dysfunction

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Anne-Françoise Rousseau · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

More and more patients survive a critical illness requiring admission to the intensive care unit, but they may be left with sequelae that are independent of the initial pathology. From a physical standpoint, the most visible complication is intensive care unit-acquired muscle weakness. A major factor in the development and persistence of muscle dysfunction appears to be the inflammatory response and the neuroendocrine stress response triggered by the initial critical insult. Persistence of inflammation beyond ICU discharge has been demonstrated in several studies. In response to inflammation, there is also increased oxidative stress associated with mitochondrial dysfunction. The objectives of the present study are therefore: to determine whether the broad inflammatory and metabolic profile of patients who have survived an ICU stay can predict the trajectory of muscle performance over the three months following ICU discharge; to compare this profile and muscle performance with those of non-critically ill surgical patients who have undergone a standardized inflammatory stress of lower intensity than that associated with critical illness; to investigate mitochondrial function in skeletal striated muscle after ICU stay, in light of the inflammatory and metabolic profile; to assess whether abnormalities in mitochondrial function also affect tissues other than skeletal muscle, in particular circulating blood mononuclear cells.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTInflammation markersmeasurement of CRP, cytokines, MPO, oxidative stress during the first 7 days after ICU admission, between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)
DIAGNOSTIC_TESTBlood nucleosomesmeasurement of blood nucleosomes between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)
DIAGNOSTIC_TESTErythrocyte membrane fatty acid contentassessment of Erythrocyte membrane fatty acid content between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)
DIAGNOSTIC_TESTmeasurement of myokinesmeasurement of myokines between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)
DIAGNOSTIC_TESTResting energy expendureassessment of REE by indirect caloriometry during the first 7 days after ICU admission, between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)
DIAGNOSTIC_TESTbody compositionassessment of body composition by BIA during the first 7 days after ICU admission, between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)
DIAGNOSTIC_TESTOmicsBlood metabolic, lipidomic, proteomic study during the first 7 days after ICU admission (or the day after surgery)
DIAGNOSTIC_TESTMonocyte profileBlood leukocyte and monocyte profiles and transcriptomic analysis between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)

Timeline

Start date
2025-12-01
Primary completion
2028-12-31
Completion
2029-04-01
First posted
2026-01-09
Last updated
2026-01-12

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT07329530. Inclusion in this directory is not an endorsement.