Tracking muscle changes over time in ICU patients with sepsis.
Characterization and Longitudinal Monitoring of Muscular Phenotype in Patients Admitted to Intensive Care for Sepsis.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de Saint-Brieuc Academic / other |
| Locations | 1 site (Saint-Brieuc) |
| Trial ID | NCT07074028 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Saint-Brieuc
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.