Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07017517

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here