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Critical Illness Myopathy as a Cause of Debilitating ICU-Acquired Weakness (MUSIC Plus)

Primary Purpose

Myopathy, Cognitive Impairment

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Biopsy/Ultrasound

About this trial

This is an interventional diagnostic trial for Myopathy focused on measuring myopathy, respiratory failure, cognitive impairment, delirium

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biopsy/Ultrasound

Arm Description

Outcomes

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.

Full Information

NCT ID

NCT00937001

First Posted

July 8, 2009

Last Updated

February 6, 2023

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT00937001

Brief Title

Critical Illness Myopathy as a Cause of Debilitating ICU-Acquired Weakness

Acronym

MUSIC Plus

Official Title

Investigating the Histopathological and Clinical Significance of Critical Illness Myopathy as a Cause of Debilitating ICU-Acquired Weakness

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2008 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopathy, Cognitive Impairment

Keywords

myopathy, respiratory failure, cognitive impairment, delirium

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biopsy/Ultrasound

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Biopsy/Ultrasound

Intervention Description

obtain muscle biopsies at approximately 14 days of ICU, muscle ultrasound at 3-4 timepoints

Primary Outcome Measure Information:

Title

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Time Frame

12 months

Title

Time Frame

12 months

Title

Time Frame

12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Hooper, MD

Organizational Affiliation

Vanderbilt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37323

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.ICUdelirium.org

Description

ICU Delirium and Cognitive Impairment Study Group website

Learn more about this trial

Critical Illness Myopathy as a Cause of Debilitating ICU-Acquired Weakness

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