Examining muscle function and quality of life in ICU patients with sepsis
Evolution of Muscle Function, Breathlessness and Quality of Life Following Intra or Extra-Abdominal Sepsis in ICU Patients
This study tests how sepsis affects muscle function and quality of life in ICU patients to see if better management strategies can be developed for those with severe infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06010186 on ClinicalTrials.gov |
What this trial studies
This study investigates the evolution of muscle function, breathlessness, and quality of life in patients suffering from sepsis or septic shock in an intensive care unit. It focuses on the impact of sepsis-induced myopathy, particularly affecting the diaphragm and intercostal muscles, which are crucial for breathing. The methodology involves ultrasound measurements of these muscles to assess their function and the overall health of the patients. The study aims to gather data that could lead to improved management strategies for patients with severe infections.
Who should consider this trial
Good fit: Ideal candidates are French-speaking adults over 18 years old who have been admitted to the ICU with sepsis or septic shock within the last 72 hours.
Not a fit: Patients with chronic muscular diseases or those who are moribund will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery strategies for ICU patients with sepsis, potentially improving their muscle function and quality of life.
How similar studies have performed: While there is existing literature on sepsis and muscle function, this specific approach using ultrasound measurements in an ICU setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years of age, * Patient admitted to a critical care unit at Paris Saint-Joseph Hospital, * Sepsis or septic shock (defined by the international consensus conference "sepsis-3"), * Sepsis/septic shock less than 72 hours old, * Patient affiliated to a health insurance scheme, * French-speaking patient, * Patient or relative who has given free, informed and express consent. Exclusion Criteria: * History of documented chronic muscular disease, whatever the cause (neuromuscular damage, abdominal or diaphragmatic hernia, muscular damage of inflammatory origin, myopathies, etc.), * Moribund patients, * Patient already included in a type 1 interventional research protocol (RIPH1), * Patient under guardianship, * Patient deprived of liberty, * Patient under court protection, * Pregnant patient.
Where this trial is running
Paris
- Hôpital Paris Saint-Joseph — Paris, France (Recruiting)
Study contacts
- Principal investigator: Johan WORMSER — Hôpital Paris Saint-Joseph
- Study coordinator: Johan WORMSER
- Email: jwormser@ghpsj.fr
- Phone: 144123085
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.