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Biopsy/Ultrasound for ICU-Acquired Weakness (MUSIC Plus Trial)

N/A

Waitlist Available

Led By Michael Hooper, MD

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients will be included if they are adult patients in a medical and/or surgical ICU receiving treatment for respiratory failure, cardiogenic shock, or septic shock.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

MUSIC Plus Trial Summary

This trial will study a group of critically ill patients to see how their muscles change during their hospital stay. The study will last for 12 months.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort at biopsy sites and risks associated with ultrasounds which are generally minimal but can include minor pain or bruising.

MUSIC Plus Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

MUSIC Plus Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To study the hypothesis that percutaneous muscle biopsy findings consistent with denervation atrophy and myopathic changes will correlate positively with the following assessments of peripheral muscle function.

Secondary outcome measures

To study the hypothesis that changes in size and density of pre-selected individual muscles, as assessed by serial bedside ultrasound, will correlate positively with the following assessments of muscle structure and function.

To study the hypothesis that development of and duration of neurocognitive impairment during critical illness will correlate with changes in muscle size and appearance as measured by serial muscle ultrasound.

To study the hypothesis that serum and muscle levels of pro-inflammatory cytokines, including IL-1, IL-6, TNF-alpha will correlate with development of ICU-Acquired weakness, as defined by characteristic muscle histopathologic findings or muscle loss.