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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to diagnose and track ICU-acquired weakness, a condition affecting many critical care patients that can cause long-lasting muscle and nerve issues. Researchers use muscle ultrasound and biopsies (removing a small tissue sample for examination) to better understand muscle changes during and after critical illness. The goal is to improve diagnosis and monitoring, potentially leading to better future treatments. This trial may suit adults currently in an ICU due to respiratory failure or shock. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance future patient care.

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 prior data suggests that this biopsy/ultrasound method is safe for ICU patients?

Research has shown that muscle ultrasound and biopsies are generally safe and well-tolerated. Muscle ultrasound checks muscle size and detects changes in individuals with nerve and muscle conditions. Studies have not identified any significant harm from using ultrasound in these cases.

Muscle biopsies involve taking a small piece of muscle tissue. Although common, this procedure can cause minor side effects like soreness or bruising at the sample site. However, studies have not reported any major safety concerns when using these methods for similar conditions.

Overall, the procedures in this study—ultrasound and biopsy—are considered safe with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using biopsy and ultrasound for ICU-acquired weakness because this approach offers a new way to understand and diagnose the condition more precisely. Unlike standard treatments that often rely on general physical assessments, this method uses detailed imaging and tissue analysis to pinpoint muscle deterioration. By providing clearer insights into the muscle changes occurring in ICU patients, this technique could lead to more personalized and effective treatment strategies.

What evidence suggests that biopsy/ultrasound is effective for ICU-acquired weakness?

Research has shown that muscle ultrasound can effectively monitor muscle size and changes in individuals who develop weakness after ICU stays. One study found that this method detected significant changes in muscle size in ICU patients, particularly those receiving high doses of steroids and drugs causing temporary paralysis. In this trial, participants will undergo both muscle ultrasound and biopsy, standard methods for diagnosing this weakness. These tools provide a clearer picture of muscle health and may help researchers understand how muscle weakness from ICU stays begins and progresses. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael Hooper, MD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Biopsy/Ultrasound Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10223702/

Neuromuscular Ultrasound in Intensive Care Unit-Acquired ... In ICUAW, the long-term outcome can be worsened by up to five years, even in milder cases with subtle levels of muscle weakness [4]. The ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666142X25000116

Potential diagnostic tools for intensive care unit acquired ... The gold standard for intensive care unit-acquired weakness diagnosis include the Medical Research Council score, muscle biopsy and electrophysiologic testing.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10718497/

Early detection and assessment of intensive care unit ... This article provides a comprehensive review of ICU-AW, focusing on the different methods used for its diagnosis and monitoring.

4. withpower.com withpower.com/trial/phase-muscular-diseases-10-2008-b337e

Biopsy/Ultrasound for ICU-Acquired Weakness ... ICU-acquired weakness represents a common and often devastating disease process which affects greater than 50% of critically ill patients.

5. annalsofintensivecare.springeropen.com annalsofintensivecare.springeropen.com/articles/10.1186/s13613-025-01500-9

Biomarkers for intensive care unit-acquired weakness Biomarkers offer potential for diagnosing, predicting, and prognosticating ICU-AW, but a comprehensive synthesis of the available evidence is still lacking.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883944125000619

ICU-acquired weakness: Critical illness myopathy and ... The incidence of ICU-acquired weakness, which includes CIM and CIP, ranges from 25 % to 84 % among long-term ventilated patients, with higher rates observed in ...

7. ejnpn.springeropen.com ejnpn.springeropen.com/articles/10.1186/s41983-024-00808-w

The use of muscle ultrasound to detect critical illness ... Critical illness myopathy (CIM) has negative impact on patient outcomes. We aimed to explore the diagnostic value of bedside ultrasonography ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11402439/

Diagnosis of “intensive care unit-acquired weakness” and “ ... In this patient cohort, 92 % met the criteria for ICUAW, only 55 % met those for CIM, and 36 % had ICUAW but did not develop CIM.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00937001

Critical Illness Myopathy as a Cause of Debilitating ICU ... To study the hypothesis that percutaneous muscle biopsy findings consistent with denervation atrophy and myopathic changes will correlate positively with the ...