Status:
ACTIVE_NOT_RECRUITING
Critical Illness Myopathy as a Cause of Debilitating ICU-Acquired Weakness
Lead Sponsor:
Vanderbilt University
Conditions:
Myopathy
Cognitive Impairment
Eligibility:
All Genders
18-99 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00937001
Start Date
November 1 2008
End Date
December 1 2025
Last Update
January 15 2025
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37323