Septic Shock
Conditions
Keywords
septic shock, CT Scan
Brief summary
Muscle dysfunction in intensive care units is associated with significant morbidity and mortality. During septic shock, there is an increased catabolism and systemic inflammation resulting in quantitative and qualitative muscle impairment. In the intensive care setting, quantitative and qualitative assessment of muscle function is challenging due to critical care environments (general anesthesia, altered consciousness, etc.). CT scan measurement at the 3rd lumbar level has been proposed to evaluate muscle function. Recent retrospective studies have highlighted increased mortality among patients with muscle mass impairment and/or decreased muscle density.
Detailed description
To date, no prospective study has assessed the prognostic value of CT scan measurements of muscle function upon admission to intensive care units for patients treated for septic shock. That is the aim of this project.
Interventions
OTHEREvaluation of muscle dysfunction in intensive care units for septic schock patients
Correlation between muscle L3 CT scan muscle derived parameters of muscle function upon intensive care unit admission and 3 months mortality after ICU discharge for patients admitted for septic shock
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients hospitalized in intensive care for septic shock defined by the presence of a documented or suspected infection, plasma lactate \>2 mmol/L, and an increase in SOFA score of more than 2 points from baseline (Singer et al., 2016) * Patients who underwent a non-contrast CT scan within 48 hours prior to admission and up to 24 hours after admission to intensive care * Patients affiliated with or eligible for social security
Exclusion criteria
* Patients with a neuromuscular disease prior to admission to intensive care. * Pregnant women * Patients under guardianship and/or conservatorship * Refusal of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| vital status | 90 days | alive or dead |
| Total muscle mass measured at L3 (cm²/m² ) | at inclusion | Total muscle mass measured at L3 by CT scan, normalized by patient height (Skeletal Muscle Index), in cm²/m² upon admission to the ICU (Correlation between three L3 CT scan parameters of muscle function upon admission to the intensive care unit and the risk of mortality at 3 months after ICU discharge in septic shock patients). |
| Total muscle density measured at L3 ( Hounsfield Unit) | at inclusion | \- Total muscle density measured at L3 by CT scan (Skeletal Muscle Density) in HU upon admission to the ICU (Correlation between three L3 CT scan parameters of muscle function upon admission to the intensive care unit and the risk of mortality at 3 months after ICU discharge in septic shock patients). |
| Total fat excretion fraction measured at L3 (%) | at inclusion | Total fat excretion fraction measured at L3 (Fat Fraction) by CT scan upon admission to the ICU (Correlation between three L3 CT scan parameters of muscle function upon admission to the intensive care unit and the risk of mortality at 3 months after ICU discharge in septic shock patients). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOFA (Sequential Organ Failure Assessment) severity score | at inclusion, 10 days. | minimum=0, maximum=3 (Worse score) |
| Kinetics of changes in muscle assessment | Day 1, 10, 90 | To assess the kinetics of changes in muscle scan parameters and muscle function. |
| Total fat excretion fraction measured at L3 (%) | at inclusion, 10 days, 90 days | Evolution of the total fat excretion fraction measured at L3 (Fat Fraction) by CT scan at inclusion, 10 days and 90 days. |
| Total muscle density measured at L3 ( Hounsfield Unit) | at inclusion, 10 days, 90 days | Evolution of total muscle density measured at L3 by CT scan (Skeletal Muscle Density) in HU upon inclusion, 10 days, 90 days |
| Total muscle mass measured at L3 (cm²/m² ) | at inclusion, 10 days, 90 days | Evolution of the total muscle mass measured at L3 by CT scan, normalized by patient height (Skeletal Muscle Index), in cm²/m² upon inclusion, 10 days, 90 days. |
| MRC score (Medical Research Council) | at discharge from intensive care, 90 days | Minimum=0 (worse score), Maximum=5 |
| Handgrip test (Kg) | at discharge from intensive care, 90 days | — |
Countries
France
Contacts
CONTACTNory Elhadjene, MD
PRINCIPAL_INVESTIGATORNory Elhadjene, MD
Centre Hospitalier Universitaire de Saint Etienne
Outcome results
None listed