TerminatedNot Applicable

ICU Associated Weakness and Bedside Ultrasound Assessment

Stopped: Coronavirus pandemic halted in-unit enrolment and participation

Canada11 participantsStarted 2019-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. adult patients (age \> 18 years);
. admitted to the ICU with a diagnosis of sepsis, and;
. an ICU duration of stay of greater than 4 days (two allow for serial assessments of muscle strength and size).

Exclusion criteria

. Any pre-existing diagnosis that would reasonably impact a participant's muscle bulk, strength, coordination, or ability to participate in the assessment
. Any activity orders or movement restrictions (including medical devices such as casts or external fixation devices) that would preclude accurate motor strength assessment.
. Dressings, casts, or medical implements that would preclude or impede ultrasound assessment of tibialis anterior muscle cross-sectional area in both legs.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation of tibialis anterior muscle atrophy development with whole-body strength

Timeframe: First two weeks of ICU admission

Trial details

NCT IDNCT04095533

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-04-01

View on ClinicalTrials.gov More Sarcopenia trials