NCT07017517 NLRP3 Inflammasome and Physical Therapy in ICU-Acquired Weakness
| NCT ID | NCT07017517 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chile |
| Condition | Critical Illness Myopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 24 participants in total. It began in 2026-04-20 with a primary completion date of 2027-05.
⚠ 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
The goal of this clinical trial is to study whether physical therapy can reduce NLRP3 inflammasome activation and muscle atrophy in patients with critical illness myopathy (CIM). It will also explore the role of NLRP3 inflammasome in the pathophysiology of CIM. The main questions this study aims to answer are: Is NLRP3 inflammasome activation associated with muscle atrophy through the upregulation of atrogenes? Does physical therapy attenuate NLRP3 inflammasome activation in skeletal muscle, thereby contributing to the prevention or reduction of muscle atrophy in CIM? Researchers will compare enhanced physical therapy using servo-assisted bed cycling (Motomed Letto®) in critically ill patients at risk of developing CIM during the early phase of ICU stay to conventional physical therapy (standard physiotherapy), to assess whether physical therapy reduces NLRP3 inflammasome activation and muscle degradation. Participants will: Be randomized to receive either conventional physical therapy or enhanced physical therapy (Motomed Letto®) for 7 consecutive days. A control group of patients without CIM will also be included. Undergo assessments of NLRP3 activity, muscle atrophy markers, and transcriptomic profiles from serum and vastus lateralis muscle biopsies. Be clinically evaluated using the SOFA scale and muscle ultrasound for CIM diagnosis. Be followed up for changes in muscle strength and physical functionality. Provide sociodemographic and clinical information to be recorded throughout the study.
Eligibility Criteria
Inclusion Criteria: * Medical diagnosis of sepsis upon ICU admission. * Receiving invasive mechanical ventilation with a projected requirement ≥7 days. * SOFA score ≥8 for three consecutive days within the first five days of ICU admission. Exclusion Criteria: * Neurocritical illness. * Prior malnutrition or cachexia. * Pre-existing neuromuscular disease. * Coagulopathy (severe liver disease or continuous dialysis). * Thrombocytopenia \<20,000 platelets/μL. * Prior Clinical Frailty Scale ≥4. * Lower limb amputation or fractures. * Ongoing chemotherapy. * Pregnancy. * BMI \>35. * Uncontrolled epilepsy. * Allergy to ultrasound gel. * Prior prolonged corticosteroid therapy. * Expected ICU stay \<7 days. * Imminent death. * Legal guardian refusal to provide informed consent.
Contact & Investigator
Paola A Llanos, PhD
STUDY DIRECTOR
University of Chile
Frequently Asked Questions
Who can join the NCT07017517 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness Myopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07017517 currently recruiting?
Yes, NCT07017517 is actively recruiting participants. Contact the research team at oscar.arellano@ug.uchile.cl for enrollment information.
Where is the NCT07017517 trial being conducted?
This trial is being conducted at Santiago, Chile, Santiago, Chile, Santiago, Chile.
Who is sponsoring the NCT07017517 clinical trial?
NCT07017517 is sponsored by University of Chile. The principal investigator is Paola A Llanos, PhD at University of Chile. The trial plans to enroll 24 participants.