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

Study acronym: MUSIC Plus
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study completion date: Dec 2025 to Dec 2026v16
  2. Minor Re-verified, no change to tracked fieldsv15
  3. Minor Study completion date: Dec 2023 to Dec 2025v14
  4. Minor Study completion date: Dec 2022 to Dec 2023v13
  5. Minor Study completion date: Dec 2021 to Dec 2022v12
Show 10 earlier versionsHide 10 earlier versions
  1. Minor Study completion date: Dec 2020 to Dec 2021v11
  2. Minor 2 versions Re-verified since Jul 15, 2019, no change to tracked fieldsv9-v10
  3. Minor Study completion date: Dec 2017 to Dec 2020v8
  4. Minor Study completion date: Dec 2016 to Dec 2017
    • Study arms: 0 to 1
    v7
  5. Minor Study completion date: Dec 2015 to Dec 2016v6
  6. Minor Study completion date: Dec 2013 to Dec 2015v5
  7. Minor Study completion date: Dec 2012 to Dec 2013v4
  8. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of May 2010 to Jan 2010
    • Study completion date: Dec 2010 to Dec 2012
    • Site details revised
    v3
  9. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00937001
Lead Sponsor Vanderbilt University
Conditions
(from sponsor)
Myopathy, Cognitive Impairment
Related terms Cognitive Dysfunction, Delirium, Muscular Diseases, Respiratory Insufficiency
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov