NCT05594550

Brief Summary

Sarcopenia is a risk factor for adverse outcome in critically ill patients. Sarcopenia might be estimated from muscle surface measure on tomodensitometry. The purpose of the study is to identify if muscle surfaces measured on thoracic tomodensitometry are associated with mortality in patients with acute respiratory distress syndrome due to SARS-Cov-2.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

October 21, 2022

Last Update Submit

October 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • measurement of muscle area at T7 level indexed in cm²/m².

    use of CT measurements to discriminate between the 2 groups (deceased versus alive)

    At hospital admission

Secondary Outcomes (4)

  • Duration of mechanical ventilation

    within the 28 days

  • Ventilator free days

    within the 28 days

  • number of days in Intensive care unit

    within the 28 days

  • number of days in hospital

    within the 28 days

Study Arms (2)

28-day survival

Alive 28 days after intensive care admission

Other: Data collectionOther: analysis of thoracic scans

28-day death

Deceased 28 days after intensive care admission

Other: Data collectionOther: analysis of thoracic scans

Interventions

Demographic data: Age, Sex, weight, height, main history and treatments. \- Biological data: CRP, PCT, albumin, pre-albumin

28-day death28-day survival

muscle area calculated on the T7 and T12 thoracic slices

28-day death28-day survival

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with acute respiratory syndrome due to SARS-Cov-2

You may qualify if:

  • patients hospitalized in intensive care for SARS-Cov-2 infection since january 2020
  • Thoracic TDM within the 30 day preceding ICU admission and up to 24 hours after ICU admission

You may not qualify if:

  • Pregnancy
  • Neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 26, 2022

Study Start

October 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10