Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07483710

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon, Lyon, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. vital status

    Time frame: 90 days

    alive or dead

  2. Total muscle mass measured at L3 (cm²/m² )

    Time frame: 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).

  3. Total muscle density measured at L3 ( Hounsfield Unit)

    Time frame: 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).

  4. Total fat excretion fraction measured at L3 (%)

    Time frame: 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 outcomes

  1. SOFA (Sequential Organ Failure Assessment) severity score

    Time frame: at inclusion, 10 days.

    minimum=0, maximum=3 (Worse score)

  2. Kinetics of changes in muscle assessment

    Time frame: Day 1, 10, 90

    To assess the kinetics of changes in muscle scan parameters and muscle function.

  3. Total fat excretion fraction measured at L3 (%)

    Time frame: 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.

  4. Total muscle density measured at L3 ( Hounsfield Unit)

    Time frame: 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

  5. Total muscle mass measured at L3 (cm²/m² )

    Time frame: 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.

  6. MRC score (Medical Research Council)

    Time frame: at discharge from intensive care, 90 days

    Minimum=0 (worse score), Maximum=5

  7. Handgrip test (Kg)

    Time frame: at discharge from intensive care, 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Nory Elhadjene, MD

CONTACT

[email protected]

(0)4.77.82.97.43 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: SIMS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 19, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.