Metabolic and Muscle Profile in ICU Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnne-Françoise Rousseau
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
anticipated ICU stay >= 7 days
Major abdominal surgery
elective surgery
Disqualifiers
Active malignancy
Inherited metabolic disorder
Known muscle disease
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Inflammation markers
Diagnostic testmeasurement 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)
Blood nucleosomes
Diagnostic testmeasurement 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)
Erythrocyte membrane fatty acid content
Diagnostic testassessment 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
Diagnostic testmeasurement 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)
Resting energy expendure
Diagnostic testassessment 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)
body composition
Diagnostic testassessment 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)
Omics
Diagnostic testBlood metabolic, lipidomic, proteomic study during the first 7 days after ICU admission (or the day after surgery)
Monocyte profile
Diagnostic testBlood 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)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ICU patientsExperimental treatment 8 interventions
Group B: Surgical patientsActive comparator 8 interventions
Trial outcomes
Primary outcomes
1
Quadriceps strength
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 patients2
Handgrip strength
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 patients3
Muscle mass
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 patients4
Muscle mass
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 the day after the surgery and 3 months after the surgery in surgical patientsOther outcomes
1
Health-related Quality of life
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 patients2
Autonomy for ADL
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 patients3
Health-related quality of life
SARQOL questionnaire (Sarcopenia and Quality Of Life questionnaire) - short form, 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 patientsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anne-Françoise Rousseau
Lead sponsor
University of Liege
Sponsor institution
Source ClinicalTrials.gov