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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
Must not have
ICU admission post cardiopulmonary resuscitation with suspected anoxic injury.
Overly moribund and not expected to survive for an additional 24 hours and / or withdrawing life support to focus on comfort measures only.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult in ICU for respiratory failure, cardiogenic shock, or septic shock.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I was admitted to the ICU after CPR due to suspected brain injury from lack of oxygen.
Select...
I am not expected to live more than 24 hours and am focusing on comfort care.
Select...
I do not have severe mental or brain conditions that stop me from living on my own.
Select...
I have had heart bypass surgery in the last 3 months.
Select...
I have a neuromuscular disease diagnosed before my current hospital stay.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Biopsy/UltrasoundExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
710 Previous Clinical Trials
6,143,329 Total Patients Enrolled
Michael Hooper, MDPrincipal InvestigatorVanderbilt University

Media Library

Biopsy/Ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT00937001 — N/A
Muscle Disease Research Study Groups: Biopsy/Ultrasound
Muscle Disease Clinical Trial 2023: Biopsy/Ultrasound Highlights & Side Effects. Trial Name: NCT00937001 — N/A
Biopsy/Ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT00937001 — N/A
~3 spots leftby Nov 2025
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