- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00937001
Critical Illness Myopathy as a Cause of Debilitating ICU-Acquired Weakness (MUSIC Plus)
January 2, 2024 updated by: Wes Ely, Vanderbilt University
Investigating the Histopathological and Clinical Significance of Critical Illness Myopathy as a Cause of Debilitating ICU-Acquired Weakness
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37323
- Vanderbilt University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
1. Patients will be included if they are adult, patients in a medical and/or surgical ICU receiving treatment for any of the following:
- respiratory failure, or
- cardiogenic or septic shock.
Exclusion Criteria:
- Cumulative ICU time > 5 days in the past 30 days, not including the current ICU stay, as this might create a state of flux regarding patients' cognitive baseline.
- Severe cognitive or neurodegenerative diseases that prevent a patient from living independently at baseline, including mental illness requiring institutionalization, acquired or congenital mental retardation, known brain lesions, traumatic brain injury, cerebrovascular accidents with resultant moderate to severe cognitive deficits or ADL dependency, Parkinson's disease, Huntington's disease, severe Alzheimer's disease or dementia of any etiology.
- ICU admission post cardiopulmonary resuscitation with suspected anoxic injury.
- An active substance abuse or psychotic disorder, or a recent (within the past 6 months) serious suicidal gesture necessitating hospitalization. This exclusion will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact.
- Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the follow-up evaluation interviews.
- Overly moribund and not expected to survive for an additional 24 hours and / or withdrawing life support to focus on comfort measures only.
- Prisoners.
- Patients who live further than 200 miles from Nashville and who do not regularly visit the Nashville area.
- Patients who are homeless and have no secondary contact person available. This exclusion will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact.
- The onset of the current episode of respiratory failure, cardiogenic shock, or septic shock was > 72 hours ago.
- Patients who have had cardiac bypass surgery within the past 3 months (including the current hospitalization).
- Patients with known Neuromuscular disease prior to admission.
- BMI > 40 or patient size that will not make percutaneous muscle biopsy and muscle ultrasound possible.
- Patients with a platelet count of less than 30,000.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biopsy/Ultrasound
|
obtain muscle biopsies at approximately 14 days of ICU, muscle ultrasound at 3-4 timepoints
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 12 months
|
12 months
|
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.
Time Frame: 12 months
|
12 months
|
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.
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Hooper, MD, Vanderbilt University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
January 1, 2010
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
July 8, 2009
First Submitted That Met QC Criteria
July 9, 2009
First Posted (Estimated)
July 10, 2009
Study Record Updates
Last Update Posted (Actual)
January 3, 2024
Last Update Submitted That Met QC Criteria
January 2, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 081235
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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