NCT07329530 Metabolic and Muscle Profile in ICU Survivors
| NCT ID | NCT07329530 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anne-Françoise Rousseau |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
More and more patients survive a critical illness requiring admission to the intensive care unit, but they may be left with sequelae that are independent of the initial pathology. From a physical standpoint, the most visible complication is intensive care unit-acquired muscle weakness. A major factor in the development and persistence of muscle dysfunction appears to be the inflammatory response and the neuroendocrine stress response triggered by the initial critical insult. Persistence of inflammation beyond ICU discharge has been demonstrated in several studies. In response to inflammation, there is also increased oxidative stress associated with mitochondrial dysfunction. The objectives of the present study are therefore: to determine whether the broad inflammatory and metabolic profile of patients who have survived an ICU stay can predict the trajectory of muscle performance over the three months following ICU discharge; to compare this profile and muscle performance with those of non-critically ill surgical patients who have undergone a standardized inflammatory stress of lower intensity than that associated with critical illness; to investigate mitochondrial function in skeletal striated muscle after ICU stay, in light of the inflammatory and metabolic profile; to assess whether abnormalities in mitochondrial function also affect tissues other than skeletal muscle, in particular circulating blood mononuclear cells.
Eligibility Criteria
Inclusion Criteria * Critical illness: * anticipated ICU stay \>= 7 days * Major abdominal surgery * elective surgery Exclusion Criteria: * Active malignancy * Inherited metabolic disorder * Known muscle disease * Pregnancy * Patient refusal * Patient unable to express informed consent (dementia, confusion) * Known coagulation disorder (cirrhosis, genetic coagulopathy) or thrombocytopenia \< 100,000/mm³ on the day of biopsy, anemia with hemoglobin \< 9 g/dL on the day of biopsy, or treatment with anticoagulant agents (contraindication to muscle biopsies only) * Pacemaker or other implanted electronic device (contraindication to bioelectrical impedance analysis only) * Oxygen therapy (contraindication to indirect calorimetry during spontaneous ventilation)
Frequently Asked Questions
Who can join the NCT07329530 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07329530 currently recruiting?
Yes, NCT07329530 is actively recruiting participants. Visit ClinicalTrials.gov or contact Anne-Françoise Rousseau to inquire about joining.
Where is the NCT07329530 trial being conducted?
This trial is being conducted at Liège, Belgium.
Who is sponsoring the NCT07329530 clinical trial?
NCT07329530 is sponsored by Anne-Françoise Rousseau. The trial plans to enroll 100 participants.