NCT05978154

Brief Summary

The goal of this observational study is to evaluate whether thigh muscle mass and muscle wasting are associated with mortality in patients who visit the emergency department. The main questions it aims to answer are:

  • Is thigh muscle mass associated with mortality in patient who visit the emergency department?
  • Does muscle wasting exist during staying in the emergency department?
  • Is muscle wasting associated with mortality in patient who visit the emergency department? Participants will be evaluated for serial thigh muscle mass using point-of-care ultrasound at the emergency department.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 28, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

July 28, 2023

Last Update Submit

July 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 28 day mortality

    28 day mortality

    28 days after study enrollment

Interventions

Thigh muscle mass and muscle wasting (exposure variable)

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who visit the emergency department with informed consent and then who undergo point-of-care ultrasound to evaluate thigh muscle mass.

You may qualify if:

  • patients who visit the emergency department of Korea University Ansan Hospital during study period
  • patients with age within the limits
  • patients who are willing to be participate the study with informed consent
  • patients who undergo point-of-care ultrasound to evaluate thigh muscle mass

You may not qualify if:

  • patients with age out of limits
  • patients who have deformities on lower leg
  • patients who is unable to maintain appropriate position to undergo point-of-care ultrasound
  • patients who decline to participate the study
  • patients who have 'do-not-resuscitate' order or are not willing to be resuscitated
  • patients of whom point-of-care ultrasound on thigh muscle mass was not performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 15355, South Korea

RECRUITING

MeSH Terms

Conditions

SepsisHeart ArrestShockWounds and Injuries

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Korea University Ansan Hospital

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 7, 2023

Study Start

July 28, 2023

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

August 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations