Tracking muscle changes over time in ICU patients with sepsis.
Official title: Characterization and Longitudinal Monitoring of Muscular Phenotype in Patients Admitted to Intensive Care for Sepsis.
Run by Centre Hospitalier de Saint-Brieuc · NCT07074028 · Data updated 2026-11-12
We will try to track muscle strength and size over time in people with sepsis in the ICU using bedside exams, ultrasounds, and electrical tests.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 63 (estimated) |
| Sponsor | Centre Hospitalier de Saint-Brieuc Academic / other |
| Locations | 1 site (Saint-Brieuc) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | June 25, 2027 |
| Study ends | June 25, 2027 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07074028 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults admitted to the participating ICU with a diagnosis of sepsis who are expected to need invasive mechanical ventilation for more than 48 hours and an ICU stay longer than 7 days, and who (or whose surrogate) can give informed consent are ideal candidates.
✕Probably not a fit
Patients who are pregnant, have active cancer, pre-existing chronic neuromuscular disease, are moribund, under legal protection, or not covered by the national health insurance are excluded and unlikely to gain benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project follows adults with sepsis admitted to an ICU and performs repeated non-invasive measurements of limb and diaphragmatic muscles during their ICU stay and up to 90 days after enrollment. Measurements include clinical strength testing (MRC-SS, handgrip), surface electromyography and electrical activity during maximal voluntary contraction, musculoskeletal and diaphragmatic ultrasound, and blood tests for inflammatory and organ dysfunction markers. Visits are scheduled at inclusion, days 3, 7, 14, 21, 28, ICU discharge, and day 90, while standard clinical care including early mobilization, physiotherapy, exercise, and nutrition is unchanged. The goal is to map the time course of muscle atrophy and dysfunction and relate these changes to clinical course and functional outcomes after ICU discharge.
Why it matters
Potential benefit: If successful, this could help clinicians detect ICU-acquired muscle weakness earlier and better target rehabilitation and ventilator-weaning strategies.
How similar studies have gone: Previous observational studies using ultrasound and EMG have documented rapid muscle loss and ICU-acquired weakness in sepsis, so this protocol builds on established methods rather than testing a novel therapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where it's running
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Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier
Saint-Brieuc, France Recruiting
Study contacts
- Study coordinator: Nicolas BARBAROT
- Email: nicolas.barbarot@armorsante.bzh
- Phone: +33(0)296017123
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.