UltrasoundNCT04353648
Assessing Muscle Metabolic Phenotype by MSK Ultrasound
An observational study of Ultrasound and CT, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test whether ultrasound images (pictures) can be used as a valid assessment of muscle quality in different muscle groups during Intensive Care stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound, CT, MuscleSound
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 5 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to a Duke Trauma center, SICU, MICO, or CT ICU
Who may be able to join
- admission Duke Trauma center, SICU, MICU, or CT ICU
- >18 years of age
Who cannot join
- <18 years of age
- prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Muscle Metabolic Phenotype by the Use of Point-of-care MSK Ultrasound Imaging.
The purpose of this study is to test whether ultrasound images (pictures) can be used as a valid assessment of muscle quality in different muscle groups during Intensive Care stay. This new approach would allow clinicians to obtain frequent skeletal muscle images and would enable doctors to observe any changes over time in muscle quality that could occur during ICU stay.
Participants in this study will have ultrasound images made of their leg-, chest- and jaw muscles taken on every day until ICU discharge.
- Conditions
- Ultrasound, CT, MuscleSound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Duke ICU/Trauma Center Patients | Any patient admitted to the Duke Trauma Center or Duke ICU will be approached to participate in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Quality from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
Ultrasound-derived area of intramuscular adipose tissue (IMAT) and intramuscular glycogen content from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
Measured: Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)
Muscle volume and thickness from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
Ultrasound-derived volume and thicknessfrom the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
Measured: Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)
Secondary outcomes (3)
Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the psoas at the Level of L3/L4
the change over time of (standard of care) CT-derived area of intramuscular adipose tissue in cm2
Measured: Up to 1 year
Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of Th3/Th4
the change over time of (standard of care) CT-derived area of intramuscular adipose tissue in cm2
Measured: Up to 1 year
Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of the head
the change over time of (standard of care) CT-derived area of intramuscular adipose tissue in cm2
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Nov 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Why it stopped: Insufficient staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Wischmeyer, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353648
- Sponsor's protocol ID
- Pro00103143
- Status last verified
- Dec 2023
- First submitted
- 14 Apr 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Muscle Metabolic Phenotype by the Use of Point-of-care MSK Ultrasound Imaging.
- ClinicalTrials.gov ID
- NCT04353648
- Acronym / sponsor ID
- Pro00103143
- Conditions
- Ultrasound, CT, MuscleSound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient staff
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 20 Apr 2020 (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 purpose of this study is to test whether ultrasound images (pictures) can be used as a valid assessment of muscle quality in different muscle groups during Intensive Care stay. This new approach would allow clinicians to obtain frequent skeletal muscle images and would enable doctors to observe any changes over time in muscle quality that could occur during ICU stay.
Participants in this study will have ultrasound images made of their leg-, chest- and jaw muscles taken on every day until ICU discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duke ICU/Trauma Center Patients | – | –Any patient admitted to the Duke Trauma Center or Duke ICU will be approached to participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to a Duke Trauma center, SICU, MICO, or CT ICU
Key inclusion criteria (2 listed)
- admission Duke Trauma center, SICU, MICU, or CT ICU
- >18 years of age
Key exclusion criteria (2 listed)
- <18 years of age
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle Quality from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
Time frame: Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)
Ultrasound-derived area of intramuscular adipose tissue (IMAT) and intramuscular glycogen content from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
Muscle volume and thickness from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
Time frame: Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)
Ultrasound-derived volume and thicknessfrom the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
3 secondary outcomes
Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the psoas at the Level of L3/L4
Time frame: Up to 1 year
Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of Th3/Th4
Time frame: Up to 1 year
Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of the head
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: Insufficient staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Ultrasound
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
Paul Wischmeyer principal investigator
Duke University
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 Ultrasound and CT, run by Duke University at 1 site in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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 United States. 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?
The study was stopped early (reason given: Insufficient staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Quality from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus (time frame: Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)). The study lists 2 primary outcomes in all. 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 19 Sep 2024.