MortalityMUSIC 2NCT07280039
Mortality and Muscle Mass Loss in Critically Ill Patients.
An observational study of Mortality and Muscle Loss, run by Brno University Hospital at 1 site in Czechia.
Trial summary
The aim of the study is to monitor changes in muscle mass in critically ill patients and to verify whether a decrease in muscle mass of ≥10% during the first 7 days of hospitalization is associated with increased 28-day mortality. We will be used ultrasound for measurement the rectus femoris cross sectional area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mortality, Muscle Loss
- How many people
- 386 participants
- Where
- 1 siteCzechia
- Study dates
- 27 Mar 2026to 15 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 will be 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
- Conditions affecting the nervous system with involvement of the thigh muscle
- Inability to cooperate during ultrasound examination
- Inability to perform ultrasound examination on day 7
- 9. Inability to perform ultrasound examination on day 7
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
The University Hospital Brno
Brno, Bohunice, 62500
Jana Fialová, M.D., +42053322305, 1149@fnbrno.cz
About this study
Official title: Mortality and Muscle Mass Loss in Critically Ill Patients: A Prospective, Observational, Multicenter Study.
The aim of the study is to monitor changes in muscle mass in critically ill patients and to verify whether a decrease in muscle mass of ≥10% during the first 7 days of hospitalization is associated with increased 28-day mortality. We will be used ultrasound for measurement the rectus femoris cross sectional area.
Read the detailed description
All patients will be admitted to participating ICU centers from December 2025 to December 2026 will be screened and enrolled based on the inclusion and exclusion criteria. Informed consent will be requested. Ultrasound measurements will be performed by the same investigator within the first 24h after ICU admission and again on day 7 of the patient´s ICU stay. All patient data will be entered into case report form by a study physician. In the follow-up will be determined 28 mortality.
- Conditions
- Mortality, Muscle Loss
- Keywords
- Mortality, Muscle loss, Muscle ultrasound, Critically ill, Rectus femoris cross area
- Medical subject headings
- Muscular Atrophy, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between muscle loss and 28 day mortality
Critically ill patients with a ≥10% decrease in rectus femoris cross-sectional area have increased 28 day mortality.
Measured: 28 days after enrollment
Secondary outcomes (2)
Incidence of a significant decrease in rectus femoris cross-sectional area
A decrease in rectus femoris cross-sectional area of 10% or more measured by ultrasound.
Measured: first 7 days of ICU stay
Incidence of an insignificant decrease in rectus femoris cross-sectional area
A decrease in rectus femoris cross-sectional area of less than 10% measured by ultrasound.
Measured: first 7 days ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start27 Mar 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies 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
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Gal, Brno University Hospital
- Investigators
- Roman Gal, M.D., PhD, Study chair, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280039
- Sponsor's protocol ID
- CT0022025
- Acronym
- MUSIC 2
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 19 Oct 2026
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Muscle Mass Loss in Critically Ill Patients: A Prospective, Observational, Multicenter Study.
- ClinicalTrials.gov ID
- NCT07280039
- Acronym / sponsor ID
- MUSIC 2 / CT0022025
- Conditions
- Mortality, Muscle Loss
- Keywords
- Mortality, Muscle loss, Muscle ultrasound, Critically ill, Rectus femoris cross area
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 12 Dec 2025 (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 aim of the study is to monitor changes in muscle mass in critically ill patients and to verify whether a decrease in muscle mass of ≥10% during the first 7 days of hospitalization is associated with increased 28-day mortality. We will be used ultrasound for measurement the rectus femoris cross sectional area.
Detailed description
All patients will be admitted to participating ICU centers from December 2025 to December 2026 will be screened and enrolled based on the inclusion and exclusion criteria. Informed consent will be requested. Ultrasound measurements will be performed by the same investigator within the first 24h after ICU admission and again on day 7 of the patient´s ICU stay. All patient data will be entered into case report form by a study physician. In the follow-up will be determined 28 mortality.
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 will be 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
- Conditions affecting the nervous system with involvement of the thigh muscle
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
Relationship between muscle loss and 28 day mortality
Time frame: 28 days after enrollment
Critically ill patients with a ≥10% decrease in rectus femoris cross-sectional area have increased 28 day mortality.
2 secondary outcomes
Incidence of a significant decrease in rectus femoris cross-sectional area
Time frame: first 7 days of ICU stay
Incidence of an insignificant decrease in rectus femoris cross-sectional area
Time frame: first 7 days ICU stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Mortality
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Not yet recruitingObservational study
Dynamic Inflammatory Changes and Nutritional Risk Scores in ICU Patients Aged 65 Years and Older
Critical Illness, Geriatric Patient
RecruitingObservational study
Observational Study to Deeply Phenotype Major Organs in Sickle Cell Disease After Curative Therapies
Mortality in Sickle Cell, Sickle Cell Cardiopulmonary Complications
RecruitingObservational study
BIO-FUNCTION for Prediction Non Relapse Mortality in Transplant and Cell Therapy
Mortality Prediction
Enrolling by invitationObservational study
Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients
Sepsis - to Reduce Mortality in the Intensive Care Unit, Burns Involving 20% or More of Body Surface
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.
Roman Gal, M.D., PhD study chair
Brno University Hospital
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 Mortality and Muscle Loss, run by Brno University Hospital 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jana Fialová, M.D. (+42053322305, 1149@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between muscle loss and 28 day mortality (time frame: 28 days after 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 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.