Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:57 AM
Ignite Modification Date:
2025-12-25 @ 2:57 AM
NCT ID:
NCT04095533
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04095533
Study Brief:
Protocol Section:
NCT04095533