SarcopeniaNCT03982628
ICU Sarcopenia Rates by Abdominal CT: Sepsis vs. Trauma
An observational study of Sarcopenia and Critical Illness, run by University of Calgary at 1 site in Canada.
Trial summary
Using abdominal computed tomography (CT) imaging, the investigators will estimate total body muscle mass at two time points in Intensive Care Unit (ICU) by assessing cross-sectional muscle areas at the L3 vertebral body level. This allows for a determination of the rate of sarcopenia development in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Critical Illness, Sepsis
- What is being tested?
- Abdominal CT imaging
- How many people
- 146 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2020to 30 Dec 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: We are comparing muscle mass estimations based on previously ordered serial abdominal CT imaging. We are comparing sepsis to a reference group of trauma without sepsis. We anticipate that the sepsis group will contain subjects with abdominal sepsis primarily (as this would be a trigger for clinically testing patients with repeat abdominal CT imaging). We anticipate the the trauma cohort will consist of primarily splenic lacerations that are being monitored clinically, although this group will also likely contain patients with liver, renal, and intestinal injuries related to trauma.
Who may be able to join
- Admitted to ICU with sepsis or trauma
- Two abdominal CT imaging tests (separated by at least 24 hours, within the first 3 weeks of their ICU admission) performed as part of their routine clinical care.
Who cannot join
- Children (age < 18 years)
- Repeat admission to ICU within the previous 6 months
- Medical or neurological diagnosis that may plausibly affect the muscle bulk of the muscles at the L3 vertebra body level (e.g. achondroplasia, spinal muscular atrophy, spinal cord injury, etc.)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary
Calgary, Alberta, T2N 2T9
Christopher J Grant, MD, 1-403-944-1580, christopher.grant@ucalgary.ca
UofC PRS Administrator, cccr@ucalgary.ca
About this study
Official title: Rates of Sarcopenia Development Using Abdominal CT Imaging in the Critically Ill With Sepsis Compared to the Critically Ill With Trauma
Using abdominal computed tomography (CT) imaging, the investigators will estimate total body muscle mass at two time points in Intensive Care Unit (ICU) by assessing cross-sectional muscle areas at the L3 vertebral body level. This allows for a determination of the rate of sarcopenia development in the ICU.
With this information, the investigators propose to test if the rates of the development of sarcopenia differ in critically ill subjects with sepsis compared to a reference group of critically ill subjects with trauma (without sepsis).
Read the detailed description
The investigators propose to compare rates of development of sarcopenia in critically ill, septic subjects with a reference cohort of critically ill, trauma subjects who are not septic. The null hypothesis is that the rates of muscle loss in subjects with sepsis (a condition associated with high levels of inflammation) are comparable with the rates of muscle loss in subjects without sepsis. As secondary outcomes, the investigators will evaluate whether rates of muscle loss correlate with clinical assessments in the ICU (body mass index, frailty score, illness severity score), with clinical course through the hospital (ICU length of stay (LOS), duration of mechanical ventilation, hospital LOS, ICU readmissions, hospital readmissions), and with outcomes (discharge destination, ICU mortality, hospital mortality and six-month mortality).
To answer this question, the investigators propose to retrospectively analyze existing abdominal CT imaging of subjects treated in the ICU. Muscle mass estimations will be performed by determining skeletal muscle cross-sectional area for muscles at the level of the L3 vertebra using previously validated techniques. The CT images will have been gathered as part of routine care for subjects admitted to a mixed medical-surgical ICU. These data will be correlated with anonymized clinical and demographic information. Study participants will be grouped into two cohorts - subjects admitted to the ICU for sepsis, and subjects admitted to the ICU for trauma. People who experience both trauma and sepsis will be excluded. Only subjects with at least 2 or more abdominal CT imaging event will be included.
Results from this study will be assessed using a generalized linear model to determine if the two groups are different. From earlier studies, the investigators estimate that 73 subjects will be required in each group to detect between-group differences for the primary outcome.
The results of this study will add to the general understanding of the rates of muscle loss in a critical care setting for subjects admitted to ICU with sepsis, as compared to subjects with trauma. Secondary outcome information will be presented descriptively to show sarcopenia rates for the two cohorts, in the context of select clinical, demographic and administrative variables.
- Conditions
- Sarcopenia, Critical Illness, Sepsis, Trauma
- Being tested
- Abdominal CT imaging
- Medical subject headings
- Sarcopenia, Critical Illness, Sepsis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal CT imagingDiagnostic test
Routine abdominal CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Adults admitted to a mixed medical/surgical ICU for sepsis with at least two abdominal CT imaging studies separated by at least 24 hours, ordered as part of their routine clinical care. Receives: Diagnostic Test: Abdominal CT imaging | |
| Trauma | Adults admitted to a mixed medical/surgical ICU for trauma (without sepsis) with at least two abdominal CT imaging studies separated by at least 24 hours, ordered as part of their routine clinical care. Receives: Diagnostic Test: Abdominal CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sarcopenia development
Described as a percentage loss of muscle mass per day (%/d)
Measured: Sarcopenia assessed over their admission to ICU (to a ceiling of the first 3 weeks of ICU)
Secondary outcomes (10)
Sarcopenia's correlation with clinical assessments in ICU - Body Mass Index
Association of sarcopenia (%/d) with body mass index (kg/m^2)
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, body mass index calculated from clinical assessment on the day of CT imaging
Sarcopenia's correlation with clinical assessments in ICU - Clinical Frailty Score
Association of sarcopenia (%/d) with clinical frailty score (a descriptive integer ranging from 1, meaning "Very Fit", to 9, meaning "Terminally Ill") as assessed by the subject's admitting ICU physician
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, clinical frailty scale assessed at admission to ICU
Sarcopenia's correlation with clinical assessments in ICU - Sequential Organ Failure Assessment (SOFA) score
Association of sarcopenia (%/d) with illness severity as described by the SOFA score (an integer between 0 and 24 where the scores are determined by the health of 6 organ systems. Higher SOFA scores indicate higher chances of mortality)
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, SOFA scores calculated from clinical variables on the first day of admission to the ICU
Sarcopenia's correlation with clinical course - ICU length of stay
Association of sarcopenia (%/d) with ICU LOS (d)
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, ICU LOS calculated from ICU admission to discharge (to a ceiling of 180 days)
Sarcopenia's correlation with clinical course - Hospital length of stay
Association of sarcopenia (%/d) with hospital LOS (d)
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, hospital LOS calculated from hospital admission to discharge (to a ceiling of 180 days)
Sarcopenia's correlation with clinical course - Duration of mechanical ventilation
Association of sarcopenia (%/d) with duration of mechanical ventilation (d)
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, duration of mechanical ventilation calculated from initiation of mechanical ventilation within the hospital stay of interest to ventilator weaning (to a ceiling of 180 days)
Sarcopenia's correlation with subject outcomes - ICU mortality
Association of sarcopenia (%/d) with percentage survival to ICU discharge (%)
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, ICU mortality calculated as the percentage of subjects who do not survive to ICU discharge (to a ceiling of 180 days)
Sarcopenia's correlation with subject outcomes - Hospital mortality
Association of sarcopenia (%/d) with percentage survival to hospital discharge (%)
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, hospital mortality calculated as the percentage of subjects who do not survive to hospital discharge (to a ceiling of 180 days)
Sarcopenia's correlation with subject outcomes - Change in living setting
Association of sarcopenia (%/d) with percentage of subjects discharged from hospital to their pre-critical illness living setting (%)
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, change in living setting calculated as the percentage of subjects discharge to an alternate living setting at hospital discharge (to a ceiling of 180 days)
Sarcopenia's correlation with subject outcomes - Six-month mortality
Association of sarcopenia (%/d) with percentage of subjects alive 180 days after their ICU admission (%)
Measured: Sarcopenia assessed over the first 3 weeks of admission to ICU, Six-month mortality calculated as the percentage of subjects deceased at 180 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start1 Aug 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
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
- Retrospective
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher J Grant, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982628
- Sponsor's protocol ID
- REB19-0595
- Status last verified
- May 2019
- First submitted
- 14 May 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
- Rates of Sarcopenia Development Using Abdominal CT Imaging in the Critically Ill With Sepsis Compared to the Critically Ill With Trauma
- ClinicalTrials.gov ID
- NCT03982628
- Acronym / sponsor ID
- REB19-0595
- Conditions
- Sarcopenia, Critical Illness, Sepsis, Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 11 Jun 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.
Using abdominal computed tomography (CT) imaging, the investigators will estimate total body muscle mass at two time points in Intensive Care Unit (ICU) by assessing cross-sectional muscle areas at the L3 vertebral body level. This allows for a determination of the rate of sarcopenia development in the ICU.
With this information, the investigators propose to test if the rates of the development of sarcopenia differ in critically ill subjects with sepsis compared to a reference group of critically ill subjects with trauma (without sepsis).
Detailed description
The investigators propose to compare rates of development of sarcopenia in critically ill, septic subjects with a reference cohort of critically ill, trauma subjects who are not septic. The null hypothesis is that the rates of muscle loss in subjects with sepsis (a condition associated with high levels of inflammation) are comparable with the rates of muscle loss in subjects without sepsis. As secondary outcomes, the investigators will evaluate whether rates of muscle loss correlate with clinical assessments in the ICU (body mass index, frailty score, illness severity score), with clinical course through the hospital (ICU length of stay (LOS), duration of mechanical ventilation, hospital LOS, ICU readmissions, hospital readmissions), and with outcomes (discharge destination, ICU mortality, hospital mortality and six-month mortality).
To answer this question, the investigators propose to retrospectively analyze existing abdominal CT imaging of subjects treated in the ICU. Muscle mass estimations will be performed by determining skeletal muscle cross-sectional area for muscles at the level of the L3 vertebra using previously validated techniques. The CT images will have been gathered as part of routine care for subjects admitted to a mixed medical-surgical ICU. These data will be correlated with anonymized clinical and demographic information. Study participants will be grouped into two cohorts - subjects admitted to the ICU for sepsis, and subjects admitted to the ICU for trauma. People who experience both trauma and sepsis will be excluded. Only subjects with at least 2 or more abdominal CT imaging event will be included.
Results from this study will be assessed using a generalized linear model to determine if the two groups are different. From earlier studies, the investigators estimate that 73 subjects will be required in each group to detect between-group differences for the primary outcome.
The results of this study will add to the general understanding of the rates of muscle loss in a critical care setting for subjects admitted to ICU with sepsis, as compared to subjects with trauma. Secondary outcome information will be presented descriptively to show sarcopenia rates for the two cohorts, in the context of select clinical, demographic and administrative variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Diagnostic Test: Abdominal CT imagingAdults admitted to a mixed medical/surgical ICU for sepsis with at least two abdominal CT imaging studies separated by at least 24 hours, ordered as part of their routine clinical care. |
| Trauma | – | Diagnostic Test: Abdominal CT imagingAdults admitted to a mixed medical/surgical ICU for trauma (without sepsis) with at least two abdominal CT imaging studies separated by at least 24 hours, ordered as part of their routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We are comparing muscle mass estimations based on previously ordered serial abdominal CT imaging. We are comparing sepsis to a reference group of trauma without sepsis. We anticipate that the sepsis group will contain subjects with abdominal sepsis primarily (as this would be a trigger for clinically testing patients with repeat abdominal CT imaging). We anticipate the the trauma cohort will consist of primarily splenic lacerations that are being monitored clinically, although this group will also likely contain patients with liver, renal, and intestinal injuries related to trauma.
Key inclusion criteria (2 listed)
- Admitted to ICU with sepsis or trauma
- Two abdominal CT imaging tests (separated by at least 24 hours, within the first 3 weeks of their ICU admission) performed as part of their routine clinical care.
Key exclusion criteria (3 listed)
- Children (age < 18 years)
- Repeat admission to ICU within the previous 6 months
- Medical or neurological diagnosis that may plausibly affect the muscle bulk of the muscles at the L3 vertebra body level (e.g. achondroplasia, spinal muscular atrophy, spinal cord injury, etc.)
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 |
|---|---|---|
| Abdominal CT imagingRoutine abdominal CT imaging | Diagnostic test | Sepsis, Trauma |
Primary outcome
Rate of sarcopenia development
Time frame: Sarcopenia assessed over their admission to ICU (to a ceiling of the first 3 weeks of ICU)
Described as a percentage loss of muscle mass per day (%/d)
10 secondary outcomes
Sarcopenia's correlation with clinical assessments in ICU - Body Mass Index
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, body mass index calculated from clinical assessment on the day of CT imaging
Sarcopenia's correlation with clinical assessments in ICU - Clinical Frailty Score
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, clinical frailty scale assessed at admission to ICU
Sarcopenia's correlation with clinical assessments in ICU - Sequential Organ Failure Assessment (SOFA) score
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, SOFA scores calculated from clinical variables on the first day of admission to the ICU
Sarcopenia's correlation with clinical course - ICU length of stay
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, ICU LOS calculated from ICU admission to discharge (to a ceiling of 180 days)
Sarcopenia's correlation with clinical course - Hospital length of stay
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, hospital LOS calculated from hospital admission to discharge (to a ceiling of 180 days)
Sarcopenia's correlation with clinical course - Duration of mechanical ventilation
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, duration of mechanical ventilation calculated from initiation of mechanical ventilation within the hospital stay of interest to ventilator weaning (to a ceiling of 180 days)
Sarcopenia's correlation with subject outcomes - ICU mortality
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, ICU mortality calculated as the percentage of subjects who do not survive to ICU discharge (to a ceiling of 180 days)
Sarcopenia's correlation with subject outcomes - Hospital mortality
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, hospital mortality calculated as the percentage of subjects who do not survive to hospital discharge (to a ceiling of 180 days)
Sarcopenia's correlation with subject outcomes - Change in living setting
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, change in living setting calculated as the percentage of subjects discharge to an alternate living setting at hospital discharge (to a ceiling of 180 days)
Sarcopenia's correlation with subject outcomes - Six-month mortality
Time frame: Sarcopenia assessed over the first 3 weeks of admission to ICU, Six-month mortality calculated as the percentage of subjects deceased at 180 days after ICU admission
Results and safety
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.
Christopher J Grant, MD principal investigator
University of Calgary
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 Critical Illness, 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 2 inclusion and 3 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher J Grant, MD (1-403-944-1580, christopher.grant@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sarcopenia development (time frame: Sarcopenia assessed over their admission to ICU (to a ceiling of the first 3 weeks of ICU)). 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.