SepsisNCT05978154
Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department
An observational study of Sepsis and Cardiac Arrest, run by Korea University Ansan Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Cardiac Arrest, Acute Respiratory Failure
- What is being tested?
- Thigh muscle mass and muscle wasting (exposure)
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jul 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who visit the emergency department with informed consent and then who undergo point-of-care ultrasound to evaluate thigh muscle mass.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
Sejoong Ahn, sejoongahn@naver.com
About this study
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.
- Conditions
- Sepsis, Cardiac Arrest, Acute Respiratory Failure, Patients Who Visit Emergency Department, Shock, Trauma
- Being tested
- Thigh muscle mass and muscle wasting (exposure)
- Medical subject headings
- Sepsis, Heart Arrest, Shock, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thigh muscle mass and muscle wasting (exposure)Other
Thigh muscle mass and muscle wasting (exposure variable)
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day mortality
28 day mortality
Measured: 28 days after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start28 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Ansan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahn, Sejoong, Korea University Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978154
- Sponsor's protocol ID
- musclemassandwastingined
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT05978154
- Acronym / sponsor ID
- musclemassandwastingined
- Conditions
- Sepsis, Cardiac Arrest, Acute Respiratory Failure, Patients Who Visit Emergency Department, Shock, Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Korea University Ansan HospitalUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visit the emergency department with informed consent and then who undergo point-of-care ultrasound to evaluate thigh muscle mass.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thigh muscle mass and muscle wasting (exposure)Thigh muscle mass and muscle wasting (exposure variable) | Other | – |
Primary outcome
28 day mortality
Time frame: 28 days after study enrollment
28 day mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Cardiac Arrest, run by Korea University Ansan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sejoong Ahn (82-10-2946-0250, sejongahn@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day mortality (time frame: 28 days after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.