Critical Illness Myopathy as a Cause of Debilitating ICU-Acquired Weakness (NCT00937001) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Critical Illness Myopathy as a Cause of Debilitating ICU-Acquired Weakness
United States50 participantsStarted 2008-11
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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.
What they're measuring
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.