NCT Number: NCT07329530
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Liège, 4000, Belgium
Location status: Recruiting
Bernard Lambermont, PhD
SUB_INVESTIGATOR
Damien Wertz, MD
SUB_INVESTIGATOR
Grégory Minguet, PhD
SUB_INVESTIGATOR
Gwaelle Ducomble
CONTACT
Quentin Maloir, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
measurement 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)
measurement 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)
assessment 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)
measurement 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)
assessment 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)
assessment 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)
Blood metabolic, lipidomic, proteomic study during the first 7 days after ICU admission (or the day after surgery)
Blood 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)
Time frame: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Quadriceps strength in Newton, measured using a handheld dynamometer (MicroFet)
Time frame: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Hangrip strength in kg, measured young an handheld dynamometer (Jamar)
Time frame: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Quadriceps muscle thickness assessed by ultrasound
Time frame: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Muscle mass assessed using bioelectrical impedance analysis
Time frame: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or perioperatively and 3 months after the surgery in surgical patients
Oxygraphy performed on a muscle sample
Time frame: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or perioperatively and 3 months after the surgery in surgical patients
Transcriptomic analysis in muscle sample (muscle biopsy)
Time frame: 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)
2-minute walking test
Time frame: 3 months after ICU discharge in the critically ill patients, or 3 months after the surgery in surgical patients
EQ-5D-3L questionnaire (3-level version of the EuroQOL questionnaire, including EQ-5D descriptive system with higher score indicating worst quality of life and the EQ visual analogue scale ranging from 0 to 100, with higher score indicating best quality of life)
Time frame: 3 months after ICU discharge in the critically ill patients, or 3 months after the surgery in surgical patients
Barthel index, ranging from 0 to 100, with higher score indicating full independency for activities of daily living
Time frame: 3 months after ICU discharge in the critically ill patients, or 3 months after the surgery in surgical patients
SARQOL questionnaire (Sarcopenia and Quality Of Life questionnaire) - short form, ranging from 0 to 100, with higher score indicating best quality of life
Anne-Françoise Rousseau
Other
Characterisation of the Inflammatory, Metabolic, and Mitochondrial Profiles in the Context of Post-Intensive Care Muscle Dysfunction
Acronym: IM3SI
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