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NLRP3 Inflammasome and Physical Therapy in ICU-Acquired Weakness

RecruitingNAAges 18 Years - anyAllUniversity of Chile
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Motomed Letto® servo-assisted cycling + standard physiotherapy
  • Standard physiotherapy
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Where

3 sites
Clínica INDISA
Santiago, Chile
Hospital de Urgencia Asistencia Pública (HUAP)
Santiago, Chile
University of Chile
Santiago, Chile
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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