Biopsy/Ultrasound for ICU-Acquired Weakness

(MUSIC Plus Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Disqualifiers: Severe cognitive diseases, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

50 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Biopsy/Ultrasound for ICU-Acquired Weakness?

The research suggests that ultrasound, a part of the Biopsy/Ultrasound treatment, is a promising tool for diagnosing and monitoring ICU-acquired weakness. It is noninvasive and can be easily used at the bedside to assess muscle thickness and detect weakness in patients. ^{1 2 3 4 5}

Is the use of biopsy/ultrasound safe for assessing ICU-acquired weakness?

Ultrasound is considered safe for assessing muscle changes in ICU patients because it is noninvasive and does not involve radiation, unlike other imaging techniques. Muscle biopsy, while more invasive, is a standard procedure used to diagnose muscle conditions and is generally safe when performed by trained professionals. ^{1 4 6 7 8}

How does the biopsy/ultrasound treatment for ICU-acquired weakness differ from other treatments?

This treatment is unique because it uses neuromuscular ultrasound, a noninvasive method, to diagnose and monitor ICU-acquired weakness by measuring muscle thickness and echo intensity, which can be done easily at the bedside. Unlike other diagnostic methods that may be difficult in sedated or ventilated patients, ultrasound offers a promising alternative that doesn't rely on patient compliance. ^{1 2 3 4 9}

What is the purpose of this trial?

ICU-acquired weakness represents a common and often devastating disease process which affects greater than 50% of critically ill patients. This pathogenesis of this acquired disease is multifactorial and results in variable severity, ranging from mild, transient to severe, permanent dysfunction of peripheral nerves in additional to muscle. In affected patients, weakness may persist for months to years after the acute phase of their illness, and has been implicated as a major contributor to decreased functional status and quality of life. Muscle ultrasound has been validated for assessment of muscle size as well as diagnosis of myopathic and neuropathic changes in patients with other known neuromuscular diseases. The use of muscle ultrasound or other imaging modalities for diagnosis or monitoring of ICU-acquired weakness has not been studied, although a single study using muscle ultrasound has shown significant change in muscle size in ICU patients receiving high dose corticosteroids and a prolonged course of paralytic agents. The investigators plan to use multiple modalities to examine skeletal muscle catabolism, function, and structure in patients during critical illness and recovery. The investigators will combine physical exam, hand grip dynamometry, electrophysiologic studies, serum biomarkers, muscle biopsies, and muscle ultrasound to assess a group of critically ill patients during their hospital stay. The investigators will obtain additional data, including neuropsychiatric assessments, severity of illness scores, administration of potentially harmful medications, and pertinent daily laboratory data. This study will last approximately 12 months.

Research Team

Michael Hooper, MD

Principal Investigator

Vanderbilt University

Eligibility Criteria

This trial is for adults in the ICU with respiratory failure, cardiogenic shock, or septic shock. It's not for those who've been in the ICU >5 days recently, have substance abuse issues, severe cognitive impairments, are prisoners, live far from Nashville without regular visits there, are homeless without contact persons, had cardiac bypass surgery within 3 months or known neuromuscular disease before admission.

Inclusion Criteria

I am an adult in ICU for respiratory failure, cardiogenic shock, or septic shock.

Exclusion Criteria

You have spent more than 5 days in the ICU in the last month, not including the current stay, which might affect your ability to think clearly.

I was admitted to the ICU after CPR due to suspected brain injury from lack of oxygen.

You are too large for a muscle biopsy or ultrasound to be performed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo multiple assessments including physical exam, hand grip dynamometry, electrophysiologic studies, serum biomarkers, muscle biopsies, and muscle ultrasound during their hospital stay

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Biopsy/Ultrasound

Trial Overview The study uses physical exams and tools like hand grip dynamometry and muscle ultrasound to assess muscle catabolism and function during critical illness. It also includes electrophysiologic studies and serum biomarkers to evaluate patients' muscles during their hospital stay.

Participant Groups

Group I: Biopsy/Ultrasound Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

References

1. China pubmed.ncbi.nlm.nih.gov

[Diagnostic accuracy of bedside ultrasound measurement of limb skeletal muscle thickness for intensive care unit-acquired weakness]. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Intensive care unit-acquired weakness-Diagnostic value of neuromuscular ultrasound]. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of quantitative neuromuscular ultrasound for the diagnosis of intensive care unit-acquired weakness: a cross-sectional observational study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A comparison of EMG and muscle biopsy in ICU weakness. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Diagnostic tools of intensive care unit acquired weakness: a systematic review]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of Different Ultrasound Methods to Assess Changes in Muscle Mass in Critically ill Patients. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Quantitative neuromuscular ultrasound in the intensive care unit. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Clinical Application of Ultrasound in Intensive Care Unit-Acquired Weakness. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Quantitative neuromuscular ultrasound in intensive care unit-acquired weakness: A systematic review. [2022]