SarcopeniaNCT04095533
ICU Associated Weakness and Bedside Ultrasound Assessment
An observational study of Sarcopenia and ICU Acquired Weakness, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, ICU Acquired Weakness
- What is being tested?
- Tibialis anterior muscle cross-sectional area assessment by ultrasound and Muscle strength assessment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include any adult participants that are admitted to a mixed medical-surgical ICU with a diagnosis of sepsis. There are no restrictions based on the source of the infection (e.g. upper respiratory tract infections vs. abdominal sepsis from a perforated viscous) and no restriction based on the treatment provided (e.g. surgery for source control vs. systemic antibiotics).
Who may be able to join
- 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).
Who cannot join
- 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.
- 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.
- Patients who are "proned" or in positions that make assessing tibialis anterior with ultrasound or physical exam impractical.
- Re-admission to ICU within the same hospital stay.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ICU Associated Weakness and Its Association With Tibialis Anterior Cross-sectional Area Changes Assessed by Serial Bedside Ultrasound Assessments
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.
Read the detailed description
BACKGROUND
Physical weakness is a common during and after critical illness. Weakness can develop for multiple reasons, but it can be generally be grouped into three overlapping categories:
- Nervous system dysfunction - weakness can result from impairments in the nervous system control of muscles;
- Muscle size reductions (i.e. sarcopenia) - muscles become smaller with disuse, and;
- Muscle force reductions (i.e. dynapenia) - muscles develop contractile impairments.
In critical care, diagnostic criteria have been developed for a syndrome of weakness called intensive care unit-acquired weakness (ICU-AW). ICU-AW has important clinical implications. It is associated with delayed ventilator weaning, increased mortality, and longer lengths of stay in the hospital. ICU-AW can also have consequences for patients after they leave the hospital. ICU-AW can be implicated in impairments in quality of life and physical function such as difficulty climbing stairs, and delays in returning to work.
Diagnosing ICU-AW is not trivial and it is centered on assessments targeted primarily to assessing dynapenia. The diagnostic criteria are clear but making the diagnosis relies on the active participation of patients, and the reliable subjective assessment by clinicians at the bedside. Factors such as sedation, restraint use, paralytic medications, pain, and dressings can all confound the assessment of a patient's strength.
To augment patient assessments, it is possible that assessments of sarcopenia might be helpful in highlighting who might be at risk for muscle dysfunction in the ICU.
RESEARCH QUESTION AND OBJECTIVES Do serial measurements of tibialis anterior muscle cross-sectional area (a muscle in the leg) using bedside ultrasound correlate with clinical weakness in people admitted to the ICU for sepsis?
Primary Outcome:
Determine if the rates of decline of tibialis anterior muscle cross-sectional areas (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate with bedside clinical measures of strength using the medical research council (MRC) sum score (a score between 0 and 60).
Secondary Outcomes:
Determine if rates of decline of tibialis anterior muscle cross-sectional areas correlate with:
- Ankle dorsiflexion strength, measured using the Medical Research Council (MRC) Scale for muscle strength (a score between 0 and 5);
- Illness severity at admission to the ICU, measured by the Sequential Organ Failure Assessment (SOFA) score (a score between 0 and 24);
- Duration of mechanical ventilation (days),
- Duration of ICU length of stay (days), and;
- Duration of hospital length of stay (days).
METHOD Each day, new admissions to a mixed medical-surgical ICU will be screened. Any person admitted with a diagnosis of sepsis will be considered for invitation to the study. Potential participants will be excluded if they are children (age < 18 years), if they have preexisting diagnoses that would plausibly affect the size of the muscles in their leg, or if they have medical conditions that would preclude an assessment of their strength. Participants who are appropriate for inclusion in the study will be approached for informed consent.
For participants who consent, every second day the cross-sectional area of the tibialis anterior muscle bulk on each leg will be measured (cm^2) using bedside ultrasound. These measurements will be accompanied by a clinical assessment of strength using the Medical Research Council (MRC) strength scale on six muscle groups bilaterally (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Participants will continue to be evaluated every other day until they leave the ICU, or until their 14th day of admission to the ICU. Chart reviews will supplement these data to allow for the determination of the secondary objectives (e.g. SOFA scores, hospital lengths of stay).
- Conditions
- Sarcopenia, ICU Acquired Weakness
- Being tested
- Tibialis anterior muscle cross-sectional area assessment by ultrasound, Muscle strength assessment
- Keywords
- critical care
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibialis anterior muscle cross-sectional area assessment by ultrasoundOther
Assessed using bedside ultrasound with repeat assessments every second day up to 2 weeks of ICU admission, or until discharge from ICU to yield an overall rate of muscle area decline reported as a %/day average muscle atrophy rate.
Tibialis anterior cross-sectional area assessments will be assessed by measurement ultrasound to both legs with portable bedside ultrasound. The cross sectional area will be measured in cm^2 at 5 cm distal to the lateral eminence of the tibial tuberosity along the muscle belly. Image processing will be performed at the bedside using features available on the ultrasound device. Muscle boundaries will be marked on the device and the cross-sectional area (computed from the perimetral contour of the muscle section) will be determined. This process will be repeated for two times for each leg.
Muscle strength assessmentOther
Assessed using clinical bedside evaluation every second day with the Medical Research Council Sum Score. This is a clinical assessment of strength of 6 different muscle groups (shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors) on each side of the body and recorded as a score between 0 (flaccid) and 5 (full strength).
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Starting at admission to ICU, patients admitted to a mixed medical-surgical ICU will be assessed every second day to determine their muscle size as measured by ultrasound, and their muscle strength as measured clinically using the Medical Research Council strength assessment at the bedside.
One-time Measures:
* Illness severity as measured by the SOFA score within the first 24 hours of admission.
* duration of mechanical ventilation
* duration of stay in the ICU
* duration of stay in the hospital Receives: Other: Tibialis anterior muscle cross-sectional area assessment by ultrasound; Other: Muscle strength assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First two weeks of ICU admission
Secondary outcomes (5)
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.
Measured: First two weeks of ICU admission
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.
Measured: First two weeks of ICU admission
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).
Measured: First two weeks of ICU admission
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).
Measured: First two weeks of ICU admission
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).
Measured: First two weeks of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: Coronavirus pandemic halted in-unit enrolment and participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095533
- Sponsor's protocol ID
- REB18-1859
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Associated Weakness and Its Association With Tibialis Anterior Cross-sectional Area Changes Assessed by Serial Bedside Ultrasound Assessments
- ClinicalTrials.gov ID
- NCT04095533
- Acronym / sponsor ID
- REB18-1859
- Conditions
- Sarcopenia, ICU Acquired Weakness
- Keywords
- critical care
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Coronavirus pandemic halted in-unit enrolment and participation
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND
Physical weakness is a common during and after critical illness. Weakness can develop for multiple reasons, but it can be generally be grouped into three overlapping categories:
- Nervous system dysfunction - weakness can result from impairments in the nervous system control of muscles;
- Muscle size reductions (i.e. sarcopenia) - muscles become smaller with disuse, and;
- Muscle force reductions (i.e. dynapenia) - muscles develop contractile impairments.
In critical care, diagnostic criteria have been developed for a syndrome of weakness called intensive care unit-acquired weakness (ICU-AW). ICU-AW has important clinical implications. It is associated with delayed ventilator weaning, increased mortality, and longer lengths of stay in the hospital. ICU-AW can also have consequences for patients after they leave the hospital. ICU-AW can be implicated in impairments in quality of life and physical function such as difficulty climbing stairs, and delays in returning to work.
Diagnosing ICU-AW is not trivial and it is centered on assessments targeted primarily to assessing dynapenia. The diagnostic criteria are clear but making the diagnosis relies on the active participation of patients, and the reliable subjective assessment by clinicians at the bedside. Factors such as sedation, restraint use, paralytic medications, pain, and dressings can all confound the assessment of a patient's strength.
To augment patient assessments, it is possible that assessments of sarcopenia might be helpful in highlighting who might be at risk for muscle dysfunction in the ICU.
RESEARCH QUESTION AND OBJECTIVES Do serial measurements of tibialis anterior muscle cross-sectional area (a muscle in the leg) using bedside ultrasound correlate with clinical weakness in people admitted to the ICU for sepsis?
Primary Outcome:
Determine if the rates of decline of tibialis anterior muscle cross-sectional areas (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate with bedside clinical measures of strength using the medical research council (MRC) sum score (a score between 0 and 60).
Secondary Outcomes:
Determine if rates of decline of tibialis anterior muscle cross-sectional areas correlate with:
- Ankle dorsiflexion strength, measured using the Medical Research Council (MRC) Scale for muscle strength (a score between 0 and 5);
- Illness severity at admission to the ICU, measured by the Sequential Organ Failure Assessment (SOFA) score (a score between 0 and 24);
- Duration of mechanical ventilation (days),
- Duration of ICU length of stay (days), and;
- Duration of hospital length of stay (days).
METHOD Each day, new admissions to a mixed medical-surgical ICU will be screened. Any person admitted with a diagnosis of sepsis will be considered for invitation to the study. Potential participants will be excluded if they are children (age < 18 years), if they have preexisting diagnoses that would plausibly affect the size of the muscles in their leg, or if they have medical conditions that would preclude an assessment of their strength. Participants who are appropriate for inclusion in the study will be approached for informed consent.
For participants who consent, every second day the cross-sectional area of the tibialis anterior muscle bulk on each leg will be measured (cm^2) using bedside ultrasound. These measurements will be accompanied by a clinical assessment of strength using the Medical Research Council (MRC) strength scale on six muscle groups bilaterally (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Participants will continue to be evaluated every other day until they leave the ICU, or until their 14th day of admission to the ICU. Chart reviews will supplement these data to allow for the determination of the secondary objectives (e.g. SOFA scores, hospital lengths of stay).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Other: Tibialis anterior muscle cross-sectional area assessment by ultrasound, Other: Muscle strength assessmentStarting at admission to ICU, patients admitted to a mixed medical-surgical ICU will be assessed every second day to determine their muscle size as measured by ultrasound, and their muscle strength as measured clinically using the Medical Research Council strength assessment at the bedside. One-time Measures: * Illness severity as measured by the SOFA score within the first 24 hours of admission. * duration of mechanical ventilation * duration of stay in the ICU * duration of stay in the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include any adult participants that are admitted to a mixed medical-surgical ICU with a diagnosis of sepsis. There are no restrictions based on the source of the infection (e.g. upper respiratory tract infections vs. abdominal sepsis from a perforated viscous) and no restriction based on the treatment provided (e.g. surgery for source control vs. systemic antibiotics).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
- Patients who are "proned" or in positions that make assessing tibialis anterior with ultrasound or physical exam impractical.
- Re-admission to ICU within the same hospital stay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibialis anterior muscle cross-sectional area assessment by ultrasoundAssessed using bedside ultrasound with repeat assessments every second day up to 2 weeks of ICU admission, or until discharge from ICU to yield an overall rate of muscle area decline reported as a %/day average muscle atrophy rate. Tibialis anterior cross-sectional area assessments will be assessed by measurement ultrasound to both legs with portable bedside ultrasound. The cross sectional area will be measured in cm^2 at 5 cm distal to the lateral eminence of the tibial tuberosity along the muscle belly. Image processing will be performed at the bedside using features available on the ultrasound device. Muscle boundaries will be marked on the device and the cross-sectional area (computed from the perimetral contour of the muscle section) will be determined. This process will be repeated for two times for each leg. | Other | Sepsis |
| Muscle strength assessmentAssessed using clinical bedside evaluation every second day with the Medical Research Council Sum Score. This is a clinical assessment of strength of 6 different muscle groups (shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors) on each side of the body and recorded as a score between 0 (flaccid) and 5 (full strength). | Other | Sepsis |
Primary outcome
Correlation of tibialis anterior muscle atrophy development with whole-body strength
Time frame: First two weeks of ICU admission
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.
5 secondary outcomes
Correlation of tibialis anterior muscle atrophy development with ankle dorsiflexion strength
Time frame: First two weeks of ICU admission
Correlation of tibialis anterior muscle atrophy development with illness severity at admission ICU
Time frame: First two weeks of ICU admission
Correlation of tibialis anterior muscle atrophy development with duration of mechanical ventilation in ICU
Time frame: First two weeks of ICU admission
Correlation of tibialis anterior muscle atrophy development with ICU length of stay
Time frame: First two weeks of ICU admission
Correlation of tibialis anterior muscle atrophy development with hospital length of stay
Time frame: First two weeks of ICU admission
Results and safety
The study was stopped early (reason given: Coronavirus pandemic halted in-unit enrolment and participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and ICU Acquired Weakness, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Coronavirus pandemic halted in-unit enrolment and participation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of tibialis anterior muscle atrophy development with whole-body strength (time frame: First two weeks of ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.