Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department

• Sponsor: Korea University Ansan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05978154
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Anticipated Duration (Months): 20.1
• Patients Per Site Per Month: 29.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Cardiac Arrest; Acute Respiratory Failure; Patients Who Visit Emergency Department; Shock; Trauma	Other: Thigh muscle mass and muscle wasting (exposure)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department
• Actual Study Start Date: Jul 28, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Mar 31, 2025

Outcome Measures

Primary Outcome Measures

1. 28 day mortality [28 days after study enrollment]

   28 day mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do	Korea, Republic of	15355

Sponsors and Collaborators

• Korea University Ansan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahn, Sejoong, Korea University Ansan Hospital, Korea University Ansan Hospital
• ClinicalTrials.gov Identifier: NCT05978154
• Other Study ID Numbers: musclemassandwastingined
• First Posted: Aug 7, 2023
• Last Update Posted: Aug 7, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Insufficiency; Muscular Atrophy; Emergencies

Study Results

No Results Posted as of Aug 7, 2023