Sarcopenia Clinical Trial
Official title:
ICU Associated Weakness and Its Association With Tibialis Anterior Cross-sectional Area Changes Assessed by Serial Bedside Ultrasound Assessments
NCT number | NCT04095533 |
Other study ID # | REB18-1859 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | April 1, 2020 |
Verified date | September 2019 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
ICU-associated weakness is a common experience for people following a critical illness. It is
associated with important patient and system-relevant outcomes. Diagnosing ICU-associated
weakness can be challenging because making the diagnosis relies on volitional participation
in strength testing by the patient in a very ill population that is often sedated or
restrained.
This study proposes to test if bedside ultrasound of tibialis anterior (a non-invasive test
that doesn't require active participation by the patient) correlates with clinical whole-body
weakness in critically ill patients admitted to an ICU with sepsis.
Status | Terminated |
Enrollment | 11 |
Est. completion date | April 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. adult patients (age > 18 years); 2. admitted to the ICU with a diagnosis of sepsis, and; 3. an ICU duration of stay of greater than 4 days (two allow for serial assessments of muscle strength and size). Exclusion Criteria: 1. Any pre-existing diagnosis that would reasonably impact a participant's muscle bulk, strength, coordination, or ability to participate in the assessment - Critical illness myopathy, critical illness neuropathy, and critical illness polyneuropathy diagnosed in the current ICU stay are not to be considered exclusion criteria as these diagnoses are directly related to the research question - Delirium is not considered an exclusion criteria for this study so long as at least two strength assessments can be performed during the course of the participant's ICU stay. 2. Any activity orders or movement restrictions (including medical devices such as casts or external fixation devices) that would preclude accurate motor strength assessment. 3. Dressings, casts, or medical implements that would preclude or impede ultrasound assessment of tibialis anterior muscle cross-sectional area in both legs. 4. Patients who are "proned" or in positions that make assessing tibialis anterior with ultrasound or physical exam impractical. 5. Re-admission to ICU within the same hospital stay. |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of tibialis anterior muscle atrophy development with whole-body strength | Determine if the rates of decline of tibialis anterior muscle cross-sectional area (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate with bedside clinical measures of strength using the MRC sum score. | First two weeks of ICU admission | |
Secondary | Correlation of tibialis anterior muscle atrophy development with ankle dorsiflexion strength | Determine if the rates of decline of tibialis anterior muscle cross-sectional area (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate with bedside clinical measures of ankle dorsiflexion strength. | First two weeks of ICU admission | |
Secondary | Correlation of tibialis anterior muscle atrophy development with illness severity at admission ICU | Determine if the rates of decline of tibialis anterior muscle cross-sectional area (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate Illness severity at admission to the ICU, measured by the Sequential Organ Failure Assessment (SOFA) score. | First two weeks of ICU admission | |
Secondary | Correlation of tibialis anterior muscle atrophy development with duration of mechanical ventilation in ICU | Determine if the rates of decline of tibialis anterior muscle cross-sectional area (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate the duration of mechanical ventilation in ICU (days). | First two weeks of ICU admission | |
Secondary | Correlation of tibialis anterior muscle atrophy development with ICU length of stay | Determine if the rates of decline of tibialis anterior muscle cross-sectional area (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate the duration of ICU admission (days). | First two weeks of ICU admission | |
Secondary | Correlation of tibialis anterior muscle atrophy development with hospital length of stay | Determine if the rates of decline of tibialis anterior muscle cross-sectional area (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate the duration of hospital admission (days). | First two weeks of ICU admission |
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