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 (SIMS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Other: Evaluation of muscle dysfunction in intensive care units for septic schock patients

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.

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: NORY ELHADJENE, MD; Phone Number: +33 (0)4.77.82.97.43; Email: nory.elhadjene@gmail.com

Study Locations

• France
  • Lyon, France, 69000
    • Hospices civils de Lyon
    • Sub-Investigator: CELINE GUICHON, MD
    • Contact: Céline GUICHON, MD; Phone Number: +33 (0)4 26 10 93 51; Email: celine.guichon@chu-lyon.fr
  • Saint-Etienne, France, 42055
    • Centre Hospitalier Universitaire de Saint-Etienne
    • Contact: NORY ELHADJENE, MD; Phone Number: +33 (0)4.77.82.97.43; Email: nory.elhadjene@gmail.com
  • Saint-Etienne, France, 42000
    • Clinique Mutualiste
    • Contact: DUPONT GUILLAUME, MD; Phone Number: +33 (0)4 77 12 12 12; Email: gdupont@mutualite-loire.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Septic shock patients; Evaluation of muscle dysfunction in intensive care units for septic shock patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vital status	alive or dead	90 days
Total muscle mass measured at L3 (cm²/m² )	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).	at inclusion
Total muscle density measured at L3 ( Hounsfield Unit)	- 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).	at inclusion
Total fat excretion fraction measured at L3 (%)	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).	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA (Sequential Organ Failure Assessment) severity score	minimum=0, maximum=3 (Worse score)	at inclusion, 10 days.
Kinetics of changes in muscle assessment	To assess the kinetics of changes in muscle scan parameters and muscle function.	Day 1, 10, 90
Total fat excretion fraction measured at L3 (%)	Evolution of the total fat excretion fraction measured at L3 (Fat Fraction) by CT scan at inclusion, 10 days and 90 days.	at inclusion, 10 days, 90 days
Total muscle density measured at L3 ( Hounsfield Unit)	Evolution of total muscle density measured at L3 by CT scan (Skeletal Muscle Density) in HU upon inclusion, 10 days, 90 days	at inclusion, 10 days, 90 days
Total muscle mass measured at L3 (cm²/m² )	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.	at inclusion, 10 days, 90 days
MRC score (Medical Research Council)	Minimum=0 (worse score), Maximum=5	at discharge from intensive care, 90 days
Handgrip test (Kg)		at discharge from intensive care, 90 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Nory Elhadjene, MD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; CT Scan
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic; Health Care Facilities Workforce and Services; Health Facilities; Hospital Units; Intensive Care Units
• Other Study ID Numbers: 25CH035; ANSM (Other Identifier: 2026-A00172-49)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No