Critical Illness, Major Abdominal Surgeries
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTInflammation markers
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)
DIAGNOSTIC_TESTBlood nucleosomes
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)
DIAGNOSTIC_TESTErythrocyte membrane fatty acid content
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)
DIAGNOSTIC_TESTmeasurement of myokines
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)
DIAGNOSTIC_TESTResting energy expendure
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)
DIAGNOSTIC_TESTbody composition
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)
DIAGNOSTIC_TESTOmics
Blood metabolic, lipidomic, proteomic study during the first 7 days after ICU admission (or the day after surgery)
DIAGNOSTIC_TESTMonocyte profile
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)
Sponsors
Anne-Françoise Rousseau
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Critical illness: * anticipated ICU stay \>= 7 days * Major abdominal surgery * elective surgery
Exclusion criteria
* Active malignancy * Inherited metabolic disorder * Known muscle disease * Pregnancy * Patient refusal * Patient unable to express informed consent (dementia, confusion) * Known coagulation disorder (cirrhosis, genetic coagulopathy) or thrombocytopenia \< 100,000/mm³ on the day of biopsy, anemia with hemoglobin \< 9 g/dL on the day of biopsy, or treatment with anticoagulant agents (contraindication to muscle biopsies only) * Pacemaker or other implanted electronic device (contraindication to bioelectrical impedance analysis only) * Oxygen therapy (contraindication to indirect calorimetry during spontaneous ventilation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical function | 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 |
| Muscle mass | 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 |
| Muscle mitochondrial function | 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 |
| Muscle function | 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) |
| Quadriceps strength | 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) |
| Handgrip strength | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Autonomy for ADL | 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 |
| Health-related quality of life | 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 |
| Health-related Quality of life | 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) |
Countries
Belgium
Outcome results
None listed