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

NCT07483710 | Not Yet Recruiting

• 2 other identifiers: 25CH035ANSM
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 3

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.

Conditions

Septic Shock

Keywords

septic shock; CT Scan

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• SOFA (Sequential Organ Failure Assessment) severity score

  at inclusion, 10 days.

• Kinetics of changes in muscle assessment

  Day 1, 10, 90

• Total fat excretion fraction measured at L3 (%)

  at inclusion, 10 days, 90 days

• Total muscle density measured at L3 ( Hounsfield Unit)

  at inclusion, 10 days, 90 days

• Total muscle mass measured at L3 (cm²/m² )

  at inclusion, 10 days, 90 days

Study Arms (1)

Septic shock patients

OTHER

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

Interventions

Evaluation of muscle dysfunction in intensive care units for septic schock patients OTHER

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

Septic shock patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with a neuromuscular disease prior to admission to intensive care.
• Pregnant women
• Patients under guardianship and/or conservatorship
• Refusal of consent.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (3)

Hospices Civils de Lyon

Lyon, 69000, France

Location

Clinique Mutualiste

Saint-Etienne, 42000, France

Location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Intensive Care Units

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Nory Elhadjene, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nory Elhadjene, MD

CONTACT

(0)4.77.82.97.43; nory.elhadjene@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (3)