Association 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. The SIMS Study

Overview

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

• Other Evaluation 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

Primary outcome measures

• vital status [Time frame: 90 days]
• Total muscle mass measured at L3 (cm²/m² ) [Time frame: at inclusion]
• Total muscle density measured at L3 ( Hounsfield Unit) [Time frame: at inclusion]
• Total fat excretion fraction measured at L3 (%) [Time frame: at inclusion]

Secondary outcome measures (7)

• SOFA (Sequential Organ Failure Assessment) severity score [Time frame: at inclusion, 10 days.]
• Kinetics of changes in muscle assessment [Time frame: Day 1, 10, 90]
• Total fat excretion fraction measured at L3 (%) [Time frame: at inclusion, 10 days, 90 days]
• Total muscle density measured at L3 ( Hounsfield Unit) [Time frame: at inclusion, 10 days, 90 days]
• Total muscle mass measured at L3 (cm²/m² ) [Time frame: at inclusion, 10 days, 90 days]
• MRC score (Medical Research Council) [Time frame: at discharge from intensive care, 90 days]
• Handgrip test (Kg) [Time frame: at discharge from intensive care, 90 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 4 centers

• Hospices Civils de Lyon — Lyon
• AP HM, Hôpital La Timone — Marseille
• Clinique Mutualiste — Saint-Etienne
• Centre Hospitalier Universitaire de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07483710 · 25CH035 · ANSM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗