Actively Recruiting
NLRP3 Inflammasome and Physical Therapy in ICU-Acquired Weakness
Led by University of Chile · Updated on 2026-05-06
24
Participants Needed
3
Research Sites
53 weeks
Total Duration
On this page
Sponsors
U
University of Chile
Lead Sponsor
C
Clinica Indisa
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NLRP3 Inflammasome and Physical Therapy in ICU-Acquired Weakness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Neurocritical illness
- Prior malnutrition or cachexia
- Pre-existing neuromuscular disease
- Coagulopathy (severe liver disease or continuous dialysis)
- Thrombocytopenia <20,000 platelets/bcL
- 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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Clínica INDISA
Santiago, Metropolitan Region, Chile, 7520440
Actively Recruiting
2
Hospital de Urgencia Asistencia Pública (HUAP)
Santiago, Metropolitan Region, Chile, 8330075
Actively Recruiting
3
University of Chile
Santiago, Metropolitan Region, Chile, 8380453
Actively Recruiting
Research Team
Ó
Óscar L Arellano-Pérez, MSc.
CONTACT
P
Paola A Llanos, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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