ICU Sarcopenia Rates by Abdominal CT: Sepsis vs. Trauma

NCT ID: NCT03982628

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2020-12-30

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).

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Abdominal CT imaging

Intervention Type: DIAGNOSTIC_TEST

Routine 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.

Abdominal CT imaging

Intervention Type: DIAGNOSTIC_TEST

Routine abdominal CT imaging

Interventions

Abdominal CT imaging

Routine abdominal CT imaging

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J Grant, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

Central Contacts

Christopher J Grant, MD

Role: CONTACT

christopher.grant@ucalgary.ca

1-403-944-1580

Sarah Manske, PhD

Role: CONTACT

smanske@ucalgary.ca

1-403-210-6046

Facility Contacts

Christopher J Grant, MD

Role: primary

christopher.grant@ucalgary.ca

1-403-944-1580

UofC PRS Administrator

Role: backup

cccr@ucalgary.ca

Other Identifiers

REB19-0595

Identifier Type: -

Identifier Source: org_study_id