ICU Sarcopenia Rates by Abdominal CT: Sepsis vs. Trauma

NCT03982628 | Unknown

• 1 other identifier: REB19-0595
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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).

Conditions

Sarcopenia; Critical Illness; Sepsis; Trauma

Outcome Measures

Primary Outcomes (1)

• Rate of sarcopenia development

  Described as a percentage loss of muscle mass per day (%/d)

  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

  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

  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

  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

  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

  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)

Study Arms (2)

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.

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.

Diagnostic Test: Abdominal CT imaging

Interventions

Abdominal CT imaging DIAGNOSTIC_TEST

Routine abdominal CT imaging

Sepsis; Trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Sarcopenia; Critical Illness; Sepsis; Wounds and Injuries

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Christopher J Grant, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher J Grant, MD

CONTACT

1-403-944-1580; christopher.grant@ucalgary.ca

Sarah Manske, PhD

CONTACT

1-403-210-6046; smanske@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: June 11, 2019
• Study Start: August 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 30, 2020
• Last Updated: April 8, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)