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).
Condition or disease | Intervention/treatment |
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Sarcopenia Critical Illness Sepsis Trauma | Diagnostic Test: Abdominal CT imaging |
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 Type : | Observational |
Estimated Enrollment : | 146 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Rates of Sarcopenia Development Using Abdominal CT Imaging in the Critically Ill With Sepsis Compared to the Critically Ill With Trauma |
Estimated Study Start Date : | August 1, 2020 |
Estimated Primary Completion Date : | December 15, 2020 |
Estimated Study Completion Date : | December 30, 2020 |
Group/Cohort | Intervention/treatment |
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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.
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Diagnostic Test: Abdominal CT imaging
Routine abdominal CT imaging
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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.
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Diagnostic Test: Abdominal CT imaging
Routine abdominal CT imaging
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christopher J Grant, MD | 1-403-944-1580 | christopher.grant@ucalgary.ca | |
Contact: Sarah Manske, PhD | 1-403-210-6046 | smanske@ucalgary.ca |
Canada, Alberta | |
University of Calgary | |
Calgary, Alberta, Canada, T2N 2T9 | |
Contact: Christopher J Grant, MD 1-403-944-1580 christopher.grant@ucalgary.ca | |
Contact: UofC PRS Administrator cccr@ucalgary.ca |
Principal Investigator: | Christopher J Grant, MD | University of Calgary |
Tracking Information | |||||
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First Submitted Date | May 14, 2019 | ||||
First Posted Date | June 11, 2019 | ||||
Last Update Posted Date | April 8, 2020 | ||||
Estimated Study Start Date | August 1, 2020 | ||||
Estimated Primary Completion Date | December 15, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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)
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | ICU Sarcopenia Rates by Abdominal CT: Sepsis vs. Trauma | ||||
Official Title | Rates of Sarcopenia Development Using Abdominal CT Imaging in the Critically Ill With Sepsis Compared to the Critically Ill With Trauma | ||||
Brief 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. 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). |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
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. | ||||
Condition |
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Intervention | Diagnostic Test: Abdominal CT imaging
Routine abdominal CT imaging
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
146 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 30, 2020 | ||||
Estimated Primary Completion Date | December 15, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03982628 | ||||
Other Study ID Numbers | REB19-0595 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | University of Calgary | ||||
Study Sponsor | University of Calgary | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University of Calgary | ||||
Verification Date | May 2019 |