SepsisREAMUSNCT07074028
Characterization and Longitudinal Monitoring of Muscular Phenotype in Patients Admitted to Intensive Care for Sepsis
A study testing Medical Research Council sum score (MRC-SS) test, Handgrip test combined with surface electromyography (sEMG) and Electrical activity during maximal voluntary contraction of the rectus femoris in people with Sepsis and Myopathy Critical Illness, run by Centre Hospitalier de Saint-Brieuc at 1 site in France.
Trial summary
Approximately 40% of patients develop muscle dysfunction during their stay in intensive care, particularly in the context of sepsis. This dysfunction represents an acquired muscle injury that is secondary to the primary illness that led to ICU admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Myopathy Critical Illness
- What is being tested?
- Medical Research Council sum score (MRC-SS) test, Handgrip test combined with surface electromyography (sEMG) and Electrical activity during maximal voluntary contraction of the rectus femoris
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2025to 25 Jun 2027
- 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
- Participants admitted to ICU with an expected length of stay greater than 7 days.
- Expected duration of invasive mechanical ventilation greater than 48 hours.
- Diagnosis of sepsis upon ICU admission (presence of an infection and a SOFA score ≥ 2, or an increase of ≥ 2 points if organ dysfunction was present prior to infection).
- Informed consent obtained from the participant or from a designated surrogate decision-maker
Who cannot join
- Pregnant women.
- Participants not affiliated with the national health insurance system.
- Participants under legal protection (guardianship or conservatorship).
- Moribund participants (end-of-life patients).
- Participants with active cancer.
- Participants with chronic neuromuscular disorders or admitted to the ICU for an acute neuromuscular condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier
Saint-Brieuc, 22000
Gwenaëlle LE GARFF, +33(0)296018048, gwenaelle.legarff@armorsante.bzh
Marie-Pierre DUBAN, +33(0)296018434, marie-pierre.duban@armorsante.bzh
About this study
Official title: Characterization and Longitudinal Monitoring of Muscular Phenotype in Patients Admitted to Intensive Care for Sepsis.
Approximately 40% of patients develop muscle dysfunction during their stay in intensive care, particularly in the context of sepsis. This dysfunction represents an acquired muscle injury that is secondary to the primary illness that led to ICU admission. It affects both the limb muscles and the respiratory muscles of the thoracic cage. Clinically, this manifests as bilateral and symmetrical muscle weakness in the limbs, and contributes significantly to difficulties in weaning patients off mechanical ventilation.
The loss of muscle mass is directly correlated with the severity of the patient's clinical condition and can reach up to 20% of initial muscle mass within just ten days. This rapid and profound atrophy primarily results from an imbalance between increased muscle protein breakdown (catabolism) and insufficient protein synthesis (anabolism). The consequences of this muscle dysfunction are significant and far-reaching, with a marked negative impact on the overall prognosis.
Read more
This condition is associated with longer durations of mechanical ventilation and extended stays in the intensive care unit. Beyond the acute phase, patients often experience persistent reductions in physical performance, leading to long-term functional limitations that impair quality of life. Furthermore, ICU-acquired muscle dysfunction has been linked to increased long-term mortality, with excess deaths reported at both one year and five years following ICU discharge. This risk is especially pronounced when the muscle dysfunction is severe and continues beyond the hospitalization period.
Several risk factors for ICU-acquired muscle dysfunction may be modifiable, opening up the possibility for preventive or therapeutic interventions. Two main factors have been identified as particularly relevant: (1) the duration of immobility and muscular inactivity, and (2) the adequacy of nutritional support, especially regarding amino acid intake, which is critical for maintaining muscle protein synthesis.
In response to these factors, early and active mobilization of ICU patients has become a key component of recommended care, often in conjunction with strategies aimed at minimizing the use of sedative medications. These practices are encouraged by international guidelines, reflecting a growing consensus around the importance of maintaining some level of muscular activity even in critically ill patients. However, despite these recommendations, no definitive evidence has demonstrated a clear improvement in patient outcomes associated with early mobilization.
This lack of clear benefit may stem from multiple factors, including the variability in patient severity across clinical trials and, importantly, the timing of the intervention. The anabolic signals triggered by muscle contraction are only effective if they are strong enough to counterbalance the catabolic signals driven by inflammation, infection, or muscle hypoxia-all of which fluctuate over the course of illness and recovery.
Regarding nutritional interventions, the appropriate timing and quantity of calorie and protein intake necessary to support adequate anabolism and mitigate muscle loss remain controversial. Although amino acids are essential for muscle protein synthesis, current studies have not shown consistent improvements in muscle function based on different nutritional strategies in the ICU setting.
Given the high prevalence of ICU-acquired muscle dysfunction in patients with sepsis, its significant impact on outcomes, and the lack of an effective, evidence-based treatment, there is a pressing need to deepen our scientific understanding of this phenomenon. Improving knowledge in this area could lead to more targeted and effective interventions, ultimately helping to preserve muscle mass and function in critically ill patients and improving both their short- and long-term prognosis.
Read the detailed description
The care provided to participants enrolled in the study remains unchanged. Standard care is administered. In particular, there are no modifications to routine practices regarding early mobilization, physiotherapy, physical exercise, or nutritional management.
The muscular phenotype of enrolled participants is assessed longitudinally during their ICU stay and after hospital discharge. Several follow-up visits are scheduled:
- Visit 1: Inclusion
- Visit 2: Day 3 (D3)
- Visit 3: Day 7 (D7)
- Visit 4: Day 14 (D14)
- Visit 5: Day 21 (D21)
- Visit 6: Day 28 (D28)
- Visit 7: ICU discharge (may occur before D28)
- Visit 8: Day 90 (D90) - End of study
During these visits, the muscular phenotype is evaluated using non-invasive methods (clinical assessments, ultrasound imaging, and electroneuromyography). Blood samples are collected to determine the inflammatory status of participants and to assess dysfunctions in vital organs.
After the ICU stay, in addition to these data, participants' physical and functional autonomy is documented. Cognitive impairments and symptoms of anxiety and depression are also recorded, along with their nutritional status.
- Conditions
- Sepsis, Myopathy Critical Illness
- Being tested
- Medical Research Council sum score (MRC-SS) test, Handgrip test combined with surface electromyography (sEMG), Electrical activity during maximal voluntary contraction of the rectus femoris, Musculoskeletal Ultrasound, Diaphragmatic ultrasound
- Keywords
- muscle atrophy, electromyography, Muscle Strength, conditioned medium with human serum
- Medical subject headings
- Sepsis, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Research Council sum score (MRC-SS) testDiagnostic test
Medical Research Council (MRC)-sumscore evaluates global muscle strength. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using MRC scale
Handgrip test combined with surface electromyography (sEMG)Diagnostic test
Handgrip test combined with surface electromyography (sEMG) of the flexor digitorum superficialis
Electrical activity during maximal voluntary contraction of the rectus femorisDiagnostic test
Surface EMG amplitude (RMS) during maximal voluntary contraction measured by surface electromyography (sEMG) of the rectus femoris
Musculoskeletal UltrasoundDevice
Measurement of the cross-sectional area (CSA) of the rectus femoris by ultrasound
Diaphragmatic ultrasoundDevice
Diaphragmatic ultrasound is a non-invasive technique that allows for sequential assessment of diaphragm mobility (excursion) and contraction (thickening) in mechanically ventilated patients
blood samplingBiological
Blood samples are collected from a radial or femoral arterial catheter, which is part of the routine care of the patients. These samples are taken with the aim to: 1) describe the inflammatory profile (plasma measurements of CRP, IL-1, IL-6, TNFα, IL-10, fibrinogen, ferritin, cortisol), 2) assess organ dysfunction and calculate the SOFA score (arterial blood gases, lactate levels, liver function tests, complete blood count, and blood electrolyte panel)
ElectroneuromyogramDevice
Analysis of peripheral neurogenic and myogenic components involved in intensive care unit-acquired muscle dysfunction through the performance of an electroneuromyogram
6-minute walk testDiagnostic test
The 6-minute walk test (6MWT) is a simple test that requires a quiet, indoor, flat 30-meter course, ideally in a straight rectangular hallway
Montreal Cognitive Assessment (MoCA)Diagnostic test
The Montreal Cognitive Assessment (MoCA) is the most sensitive rapid assessment test and assesses cognitive functions most broadly (attention, concentration, executive functions, memory, language, visual-constructive abilities, abstraction, calculation, orientation).
MNA-SFBehavioural
The MNA-SF (Short Form) is a simplified version that allows us to determine whether the elderly person is well nourished, at risk of malnutrition or malnourished.
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal characterization of muscle phenotype in ICU participants with sepsis | Experimental | Through successive visits during and after the ICU stay, the muscle phenotype of participants is determined using non-invasive data collection methods (clinical assessments, ultrasound imaging, and electroneuromyography). Blood samples are harvested to assess the participants' inflammatory status and evaluate organ dysfunction.
Following the ICU stay, in addition to the previously mentioned data, participants' physical and functional autonomy is assessed. Cognitive impairments and symptoms of anxiety and depression are also recorded, along with their nutritional status. Receives: Diagnostic Test: Medical Research Council sum score (MRC-SS) test; Diagnostic Test: Handgrip test combined with surface electromyography (sEMG); Diagnostic Test: Electrical activity during maximal voluntary contraction of the rectus femoris; Device: Musculoskeletal Ultrasound; Device: Diaphragmatic ultrasound; Biological: blood sampling; Device: Electroneuromyogram; Diagnostic Test: 6-minute walk test; Diagnostic Test: Montreal Cognitive Assessment (MoCA); Behavioral: MNA-SF |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRC score (Medical Research Council).
The MRC score allows for a global assessment of muscle function in ICU patients. An MRC score below 48, measured on day 28 or at ICU discharge (if discharge occurs before day 28), defines ICU-acquired weakness (ICU-AW).
Measured: From enrollment to the end of the participant's study period (maximum 90 days)
Secondary outcomes (10)
Handgrip test combined with surface electromyography (sEMG)
Handgrip test combined with surface electromyography (sEMG) of the flexor digitorum superficialis
Measured: From enrollment to the end of the participant's study period (maximum 90 days)
Electrical activity during maximal voluntary contraction of the rectus femoris
Surface EMG amplitude (RMS) during maximal voluntary contraction measured by surface electromyography (sEMG) of the rectus femoris
Measured: From enrollment to the end of the participant's study period (maximum 90 days)
Musculoskeletal Ultrasound
Measurement of the cross-sectional area (CSA) of the rectus femoris by ultrasound
Measured: From enrollment to the end of the participant's study period (maximum 90 days)
Diaphragmatic ultrasound
Diaphragmatic ultrasound is a non-invasive technique that allows for sequential assessment of diaphragm mobility (excursion) and contraction (thickening) in mechanically ventilated patients
Measured: From enrollment to the end of the participant's study period (maximum 90 days)
Electroneuromyogram
Analysis of peripheral neurogenic and myogenic components involved in intensive care unit-acquired muscle dysfunction through the performance of an electroneuromyogram
Measured: Only during the last visit of the protocol : 90 days after the inclusion
Plasma concentrations of inflammation-related proteins
Blood samples are collected from a radial or femoral arterial catheter, which is part of the routine care of the patients. These samples are taken with the aim to describe the plasma inflammatory profile including CRP, IL-1, IL-6, TNFα, IL-10, fibrinogen, ferritin and cortisol concentrations. All these data are reported in a Outcome Measure results data table.
Measured: From enrollment to the end of the participant's study period (maximum 90 days)
Organ dysfunction assesment
Blood samples are collected from a radial or femoral arterial catheter, which is part of the routine care of the patients. These samples are taken with the aim to assess organ dysfunction and calculate the SOFA score (arterial blood gases, lactate levels, liver function tests, complete blood count, and blood electrolyte panel).
Measured: From enrollment to the end of the participant's study period (maximum 90 days)
6-minute walk test
The 6-minute walk test (6MWT) is a simple test that requires a quiet, indoor, flat 30-meter course, ideally in a straight rectangular hallway
Measured: Only during the last visit of the protocol : 90 days after the inclusion
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is the most sensitive rapid assessment test and assesses cognitive functions most broadly (attention, concentration, executive functions, memory, language, visual-constructive abilities, abstraction, calculation, orientation).
Measured: Only during the last visit of the protocole : 90 days after the inclusion
MNA-SF
The MNA-SF (Short Form) is a simplified version that allows us to determine whether the elderly person is well nourished, at risk of malnutrition or malnourished.
Measured: Only during the last visit of the protocol : 90 days after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start25 Mar 2025
- Primary completion25 Jun 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Brieuc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074028
- Sponsor's protocol ID
- 2024_CHSB_REAMUS
- Other IDs
- 2024-A02380-47
- Acronym
- REAMUS
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Longitudinal Monitoring of Muscular Phenotype in Patients Admitted to Intensive Care for Sepsis.
- ClinicalTrials.gov ID
- NCT07074028
- Acronym / sponsor ID
- REAMUS / 2024_CHSB_REAMUS
- Conditions
- Sepsis, Myopathy Critical Illness
- Keywords
- muscle atrophy, electromyography, Muscle Strength, conditioned medium with human serum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-BrieucUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 20 Jul 2025 (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.
Approximately 40% of patients develop muscle dysfunction during their stay in intensive care, particularly in the context of sepsis. This dysfunction represents an acquired muscle injury that is secondary to the primary illness that led to ICU admission. It affects both the limb muscles and the respiratory muscles of the thoracic cage. Clinically, this manifests as bilateral and symmetrical muscle weakness in the limbs, and contributes significantly to difficulties in weaning patients off mechanical ventilation.
The loss of muscle mass is directly correlated with the severity of the patient's clinical condition and can reach up to 20% of initial muscle mass within just ten days. This rapid and profound atrophy primarily results from an imbalance between increased muscle protein breakdown (catabolism) and insufficient protein synthesis (anabolism). The consequences of this muscle dysfunction are significant and far-reaching, with a marked negative impact on the overall prognosis.
This condition is associated with longer durations of mechanical ventilation and extended stays in the intensive care unit. Beyond the acute phase, patients often experience persistent reductions in physical performance, leading to long-term functional limitations that impair quality of life. Furthermore, ICU-acquired muscle dysfunction has been linked to increased long-term mortality, with excess deaths reported at both one year and five years following ICU discharge. This risk is especially pronounced when the muscle dysfunction is severe and continues beyond the hospitalization period.
Several risk factors for ICU-acquired muscle dysfunction may be modifiable, opening up the possibility for preventive or therapeutic interventions. Two main factors have been identified as particularly relevant: (1) the duration of immobility and muscular inactivity, and (2) the adequacy of nutritional support, especially regarding amino acid intake, which is critical for maintaining muscle protein synthesis.
In response to these factors, early and active mobilization of ICU patients has become a key component of recommended care, often in conjunction with strategies aimed at minimizing the use of sedative medications. These practices are encouraged by international guidelines, reflecting a growing consensus around the importance of maintaining some level of muscular activity even in critically ill patients. However, despite these recommendations, no definitive evidence has demonstrated a clear improvement in patient outcomes associated with early mobilization.
This lack of clear benefit may stem from multiple factors, including the variability in patient severity across clinical trials and, importantly, the timing of the intervention. The anabolic signals triggered by muscle contraction are only effective if they are strong enough to counterbalance the catabolic signals driven by inflammation, infection, or muscle hypoxia-all of which fluctuate over the course of illness and recovery.
Regarding nutritional interventions, the appropriate timing and quantity of calorie and protein intake necessary to support adequate anabolism and mitigate muscle loss remain controversial. Although amino acids are essential for muscle protein synthesis, current studies have not shown consistent improvements in muscle function based on different nutritional strategies in the ICU setting.
Given the high prevalence of ICU-acquired muscle dysfunction in patients with sepsis, its significant impact on outcomes, and the lack of an effective, evidence-based treatment, there is a pressing need to deepen our scientific understanding of this phenomenon. Improving knowledge in this area could lead to more targeted and effective interventions, ultimately helping to preserve muscle mass and function in critically ill patients and improving both their short- and long-term prognosis.
Detailed description
The care provided to participants enrolled in the study remains unchanged. Standard care is administered. In particular, there are no modifications to routine practices regarding early mobilization, physiotherapy, physical exercise, or nutritional management.
The muscular phenotype of enrolled participants is assessed longitudinally during their ICU stay and after hospital discharge. Several follow-up visits are scheduled:
- Visit 1: Inclusion
- Visit 2: Day 3 (D3)
- Visit 3: Day 7 (D7)
- Visit 4: Day 14 (D14)
- Visit 5: Day 21 (D21)
- Visit 6: Day 28 (D28)
- Visit 7: ICU discharge (may occur before D28)
- Visit 8: Day 90 (D90) - End of study
During these visits, the muscular phenotype is evaluated using non-invasive methods (clinical assessments, ultrasound imaging, and electroneuromyography). Blood samples are collected to determine the inflammatory status of participants and to assess dysfunctions in vital organs.
After the ICU stay, in addition to these data, participants' physical and functional autonomy is documented. Cognitive impairments and symptoms of anxiety and depression are also recorded, along with their nutritional status.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal characterization of muscle phenotype in ICU participants with sepsis | Experimental | Diagnostic Test: Medical Research Council sum score (MRC-SS) test, Diagnostic Test: Handgrip test combined with surface electromyography (sEMG), Diagnostic Test: Electrical activity during maximal voluntary contraction of the rectus femoris, Device: Musculoskeletal Ultrasound, Device: Diaphragmatic ultrasound, Biological: blood sampling, Device: Electroneuromyogram, Diagnostic Test: 6-minute walk test, Diagnostic Test: Montreal Cognitive Assessment (MoCA), Behavioral: MNA-SFThrough successive visits during and after the ICU stay, the muscle phenotype of participants is determined using non-invasive data collection methods (clinical assessments, ultrasound imaging, and electroneuromyography). Blood samples are harvested to assess the participants' inflammatory status and evaluate organ dysfunction. Following the ICU stay, in addition to the previously mentioned data, participants' physical and functional autonomy is assessed. Cognitive impairments and symptoms of anxiety and depression are also recorded, along with their nutritional status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants admitted to ICU with an expected length of stay greater than 7 days.
- Expected duration of invasive mechanical ventilation greater than 48 hours.
- Diagnosis of sepsis upon ICU admission (presence of an infection and a SOFA score ≥ 2, or an increase of ≥ 2 points if organ dysfunction was present prior to infection).
- Informed consent obtained from the participant or from a designated surrogate decision-maker
Key exclusion criteria (6 listed)
- Pregnant women.
- Participants not affiliated with the national health insurance system.
- Participants under legal protection (guardianship or conservatorship).
- Moribund participants (end-of-life patients).
- Participants with active cancer.
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 |
|---|---|---|
| Medical Research Council sum score (MRC-SS) testMedical Research Council (MRC)-sumscore evaluates global muscle strength. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using MRC scale | Diagnostic test | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
| Handgrip test combined with surface electromyography (sEMG)Handgrip test combined with surface electromyography (sEMG) of the flexor digitorum superficialis | Diagnostic test | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
| Electrical activity during maximal voluntary contraction of the rectus femorisSurface EMG amplitude (RMS) during maximal voluntary contraction measured by surface electromyography (sEMG) of the rectus femoris | Diagnostic test | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
| Musculoskeletal UltrasoundMeasurement of the cross-sectional area (CSA) of the rectus femoris by ultrasound | Device | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
| Diaphragmatic ultrasoundDiaphragmatic ultrasound is a non-invasive technique that allows for sequential assessment of diaphragm mobility (excursion) and contraction (thickening) in mechanically ventilated patients | Device | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
| blood samplingBlood samples are collected from a radial or femoral arterial catheter, which is part of the routine care of the patients. These samples are taken with the aim to: 1) describe the inflammatory profile (plasma measurements of CRP, IL-1, IL-6, TNFα, IL-10, fibrinogen, ferritin, cortisol), 2) assess organ dysfunction and calculate the SOFA score (arterial blood gases, lactate levels, liver function tests, complete blood count, and blood electrolyte panel) | Biological | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
| ElectroneuromyogramAnalysis of peripheral neurogenic and myogenic components involved in intensive care unit-acquired muscle dysfunction through the performance of an electroneuromyogram | Device | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
| 6-minute walk testThe 6-minute walk test (6MWT) is a simple test that requires a quiet, indoor, flat 30-meter course, ideally in a straight rectangular hallway | Diagnostic test | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
| Montreal Cognitive Assessment (MoCA)The Montreal Cognitive Assessment (MoCA) is the most sensitive rapid assessment test and assesses cognitive functions most broadly (attention, concentration, executive functions, memory, language, visual-constructive abilities, abstraction, calculation, orientation). | Diagnostic test | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
| MNA-SFThe MNA-SF (Short Form) is a simplified version that allows us to determine whether the elderly person is well nourished, at risk of malnutrition or malnourished. | Behavioural | Longitudinal characterization of muscle phenotype in ICU participants with sepsis |
Primary outcome
MRC score (Medical Research Council).
Time frame: From enrollment to the end of the participant's study period (maximum 90 days)
The MRC score allows for a global assessment of muscle function in ICU patients. An MRC score below 48, measured on day 28 or at ICU discharge (if discharge occurs before day 28), defines ICU-acquired weakness (ICU-AW).
10 secondary outcomes
Handgrip test combined with surface electromyography (sEMG)
Time frame: From enrollment to the end of the participant's study period (maximum 90 days)
Electrical activity during maximal voluntary contraction of the rectus femoris
Time frame: From enrollment to the end of the participant's study period (maximum 90 days)
Musculoskeletal Ultrasound
Time frame: From enrollment to the end of the participant's study period (maximum 90 days)
Diaphragmatic ultrasound
Time frame: From enrollment to the end of the participant's study period (maximum 90 days)
Electroneuromyogram
Time frame: Only during the last visit of the protocol : 90 days after the inclusion
Plasma concentrations of inflammation-related proteins
Time frame: From enrollment to the end of the participant's study period (maximum 90 days)
Organ dysfunction assesment
Time frame: From enrollment to the end of the participant's study period (maximum 90 days)
6-minute walk test
Time frame: Only during the last visit of the protocol : 90 days after the inclusion
Montreal Cognitive Assessment (MoCA)
Time frame: Only during the last visit of the protocole : 90 days after the inclusion
MNA-SF
Time frame: Only during the last visit of the protocol : 90 days after the inclusion
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 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Research Council sum score (MRC-SS) test, Handgrip test combined with surface electromyography (sEMG) and Electrical activity during maximal voluntary contraction of the rectus femoris in people with Sepsis and Myopathy Critical Illness, run by Centre Hospitalier de Saint-Brieuc at 1 site 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 4 inclusion and 6 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Nicolas BARBAROT (+33(0)296017123, nicolas.barbarot@armorsante.bzh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRC score (Medical Research Council). (time frame: From enrollment to the end of the participant's study period (maximum 90 days)). 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 26 Oct 2026.