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

Recruiting in Palo Alto (17 mi)

Overseen byMichael Hooper, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University

No Placebo Group

Trial Summary

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.

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.

See 11 more

Treatment Details

Interventions

Biopsy/Ultrasound (Other)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Biopsy/UltrasoundExperimental Treatment1 Intervention