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

NCT00937001 | Active Not Recruiting DMC

• 1 other identifier: 081235
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopathy; Cognitive Impairment

Keywords

myopathy; respiratory failure; cognitive impairment; delirium

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• 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.

  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.

  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.

  12 month

Study Arms (1)

Biopsy/Ultrasound

EXPERIMENTAL

Procedure: Biopsy/Ultrasound

Interventions

Biopsy/Ultrasound PROCEDURE

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

Biopsy/Ultrasound

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37323, United States

Location

Related Links

• ICU Delirium and Cognitive Impairment Study Group website

MeSH Terms

Conditions

Muscular Diseases; Cognitive Dysfunction; Respiratory Insufficiency; Delirium

Interventions

Biopsy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Michael Hooper, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)