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)

July 8, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Lyon, France, 69000
        • Not yet recruiting
        • Hospices Civils De Lyon
        • Sub-Investigator:
          • CELINE GUICHON, MD
        • Contact:
      • Marseille, France, 13385
        • Not yet recruiting
        • AP HM, Hôpital La Timone
        • Contact:
        • Sub-Investigator:
          • Bénédicte GRIGORESCO, MD
      • Saint-Etienne, France, 42055
        • Recruiting
        • Centre Hospitalier Universitaire de Saint-Etienne
        • Sub-Investigator:
          • Rémi GRANGE, MD
        • Sub-Investigator:
          • Sylvain GRANGE, MD
        • Sub-Investigator:
          • Léonard FEASSON, MD PhD
        • Sub-Investigator:
          • Pierre CROISILLE, MD PhD
        • Sub-Investigator:
          • Jérôme MOREL, MD PhD
        • Contact:
        • Sub-Investigator:
          • Nicolas MAILLARD, MD PhD
        • Sub-Investigator:
          • Guillaume THIERRY, MD PhD
        • Sub-Investigator:
          • Sophie PERINEL-RAGEY, MD PhD
      • Saint-Etienne, France, 42000
        • Not yet recruiting
        • Clinique Mutualiste
        • Contact:
        • Sub-Investigator:
          • Bachir HAG, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
vital status
Time Frame: 90 days
alive or dead
90 days
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).
at inclusion
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).
at inclusion
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).
at inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SOFA (Sequential Organ Failure Assessment) severity score
Time Frame: at inclusion, 10 days.
minimum=0, maximum=3 (Worse score)
at inclusion, 10 days.
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.
Day 1, 10, 90
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.
at inclusion, 10 days, 90 days
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
at inclusion, 10 days, 90 days
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.
at inclusion, 10 days, 90 days
MRC score (Medical Research Council)
Time Frame: at discharge from intensive care, 90 days
Minimum=0 (worse score), Maximum=5
at discharge from intensive care, 90 days
Handgrip test (Kg)
Time Frame: at discharge from intensive care, 90 days
at discharge from intensive care, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nory Elhadjene, MD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25CH035
  • ANSM (Other Identifier: 2025-A02337-42)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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