Septic ShockSIMSNCT07483710
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
A study testing Evaluation of muscle dysfunction in intensive care units for septic schock patients in people with Septic Shock, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Evaluation of muscle dysfunction in intensive care units for septic schock patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 4 sitesFrance
- Study dates
- 19 Mar 2026to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with a neuromuscular disease prior to admission to intensive care.
- Pregnant women
- Patients under guardianship and/or conservatorship
- Refusal of consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Hospices Civils de Lyon
Lyon, 69000
Céline GUICHON, MD, (0)4 26 10 93 51 ext. +33, celine.guichon@chu-lyon.fr
CELINE GUICHON, MD
- Not yet recruiting
AP HM, Hôpital La Timone
Marseille, 13385
Pierre SIMEONE, MD, (0)4 91 38 00 00 ext. +33, pierre.simeone@ap-hm.fr
Bénédicte GRIGORESCO, MD
- Not yet recruiting
Clinique Mutualiste
Saint-Etienne, 42000
DUPONT GUILLAUME, MD, (0)4 77 12 12 12 ext. +33, gdupont@mutualite-loire.com
Bachir HAG, MD
- Recruiting
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055
NORY ELHADJENE, MD, (0)4.77.82.97.43 ext. +33, nory.elhadjene@gmail.com
Jérôme MOREL, MD PhD
About this 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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Evaluation of muscle dysfunction in intensive care units for septic schock patients
- Keywords
- septic shock, CT Scan
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of muscle dysfunction in intensive care units for septic schock patientsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Septic shock patients | Other | Evaluation of muscle dysfunction in intensive care units for septic shock patients Receives: Other: Evaluation of muscle dysfunction in intensive care units for septic schock patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital status
alive or dead
Measured: 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).
Measured: 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).
Measured: 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).
Measured: at inclusion
Secondary outcomes (7)
SOFA (Sequential Organ Failure Assessment) severity score
minimum=0, maximum=3 (Worse score)
Measured: at inclusion, 10 days.
Kinetics of changes in muscle assessment
To assess the kinetics of changes in muscle scan parameters and muscle function.
Measured: 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.
Measured: 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
Measured: 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.
Measured: at inclusion, 10 days, 90 days
MRC score (Medical Research Council)
Minimum=0 (worse score), Maximum=5
Measured: at discharge from intensive care, 90 days
Handgrip test (Kg)
Measured: at discharge from intensive care, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start19 Mar 2026
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nory Elhadjene, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483710
- Sponsor's protocol ID
- 25CH035
- Other IDs
- ANSM
- Acronym
- SIMS
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07483710
- Acronym / sponsor ID
- SIMS / 25CH035
- Conditions
- Septic Shock
- Keywords
- septic shock, CT Scan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Septic shock patients | Other | Other: Evaluation of muscle dysfunction in intensive care units for septic schock patientsEvaluation of muscle dysfunction in intensive care units for septic shock patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients with a neuromuscular disease prior to admission to intensive care.
- Pregnant women
- Patients under guardianship and/or conservatorship
- Refusal of consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of muscle dysfunction in intensive care units for septic schock patientsCorrelation 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 | Other | Septic shock patients |
Primary outcome
vital status
Time frame: 90 days
alive or dead
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).
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).
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).
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
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Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nory Elhadjene, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of muscle dysfunction in intensive care units for septic schock patients in people with Septic Shock, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nory Elhadjene, MD ((0)4.77.82.97.43 ext. +33, nory.elhadjene@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital status (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.