Muscle LossMUSICNCT03865095
Muscle Mass Loss in Critically Ill Patients.
An observational study of Muscle Loss, run by Masaryk University at 1 site in Czechia.
Trial summary
The purpose of the study is to describe the change in muscle mass in critically ill patients. The study will examine rectus femoris cross sectional area with ultrasound and identify risk factors of this changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Loss
- How many people
- 104 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Mar 2019to 14 Nov 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: Critically ill adult patients admitted to intensive care unit with suspect length of artificial ventilation more than 48 hours.
Who may be able to join
- age ≥18 years
- mechanical ventilation expected for at least 48 hours
Who cannot join
- Clinical Frailty Score above 7 prior admission
- neuromuscular disease in previous medical history
- amputated lower extremities
- trauma of lower extremities involving tights
- age under 18 years
- inability to perform ultrasound examination
- death or discharge prior completion of protocol
- full verticalization prior completion of protocol
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Brno and Masaryk University Brno
Brno, 62500
About this study
Official title: Muscle Mass Loss in Critically Ill and Its Risk Factors. A Prospective Observational Study.
The purpose of the study is to describe the change in muscle mass in critically ill patients. The study will examine rectus femoris cross sectional area with ultrasound and identify risk factors of this changes.
Read the detailed description
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of March 2019 to the 31st of August 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Ultrasound measurement of rectus femoris cross sectional area will be performed in first 24 hours after admission to ICU.
Study data will be entered in study form. The ultrasound measurement will be repeated on day 7 of hospitalisation.
Changes in rectus femoris cross sectional area and potential risk factors will be analysed. The length of ICU length of stay and 28-day mortality will be also monitored.
- Conditions
- Muscle Loss
- Keywords
- Critical Care, Muscle loss, Rectus femoris cross sectional area, Muscle ultrasound
- Medical subject headings
- Muscular Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass loss
Change in cross sectional area of rectus femoris muscle estimated by ultrasound
Measured: 7 days
Secondary outcomes (1)
28 day mortality
mortality 28 days after enrolment
Measured: 28 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start25 Mar 2019
- Primary completion14 Oct 2020
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle LossStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital
- Responsible party
- Sponsor
- Investigators
- Roman Gal, M.D., PhD., Study chair, University Hospital Brno and Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865095
- Sponsor's protocol ID
- CT0012019
- Acronym
- MUSIC
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hrdy O, Vrbica K, Kovar M, Korbicka T, Stepanova R, Gal R. Incidence of muscle wasting in the critically ill: a prospective observational cohort study. Sci Rep. 2023 Jan 13;13(1):742. doi: 10.1038/s41598-023-28071-8.
PubMed 36639540
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Mass Loss in Critically Ill and Its Risk Factors. A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT03865095
- Acronym / sponsor ID
- MUSIC / CT0012019
- Conditions
- Muscle Loss
- Keywords
- Critical Care, Muscle loss, Rectus femoris cross sectional area, Muscle ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Brno University Hospital
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 6 Mar 2019 (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 the study is to describe the change in muscle mass in critically ill patients. The study will examine rectus femoris cross sectional area with ultrasound and identify risk factors of this changes.
Detailed description
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of March 2019 to the 31st of August 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Ultrasound measurement of rectus femoris cross sectional area will be performed in first 24 hours after admission to ICU.
Study data will be entered in study form. The ultrasound measurement will be repeated on day 7 of hospitalisation.
Changes in rectus femoris cross sectional area and potential risk factors will be analysed. The length of ICU length of stay and 28-day mortality will be also monitored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients admitted to intensive care unit with suspect length of artificial ventilation more than 48 hours.
Key inclusion criteria (2 listed)
- age ≥18 years
- mechanical ventilation expected for at least 48 hours
Key exclusion criteria (8 listed)
- Clinical Frailty Score above 7 prior admission
- neuromuscular disease in previous medical history
- amputated lower extremities
- trauma of lower extremities involving tights
- age under 18 years
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 mass loss
Time frame: 7 days
Change in cross sectional area of rectus femoris muscle estimated by ultrasound
1 secondary outcome
28 day mortality
Time frame: 28 days after enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 36639540Hrdy O, Vrbica K, Kovar M, Korbicka T, Stepanova R, Gal R. Incidence of muscle wasting in the critically ill: a prospective observational cohort study. Sci Rep. 2023 Jan 13;13(1):742. doi: 10.1038/s41598-023-28071-8.
- 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.
Roman Gal, M.D., PhD. study chair
University Hospital Brno and Masaryk 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 Muscle Loss, run by Masaryk University at 1 site in Czechia.
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 8 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: finished, as of the sponsor's last update on 3 Mar 2021. 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 Czechia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 mass loss (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865095, which also lists 1 linked publication.
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 3 Mar 2021.