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Not yet recruitingNCT07280039MUSIC 2Updated Dec 12, 2025

Mortality and Muscle Mass Loss in Critically Ill Patients.

An observational study in Mortality and Muscle Loss, sponsored by Brno University Hospital. Not yet recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.

Sponsored by Brno University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
386
Ages
18 Years and older
Sex
All
01

Study 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 ultrasoud 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 admssion 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.

02

Conditions studied

  • Mortality
  • Muscle Loss

Keywords

  • Mortality
  • Muscle loss
  • Muscle ultrasound
  • Critically ill
  • Rectus femoris cross area
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill adult patients will be admitted to intensive care unit with suspect length of artificial ventilation more than 48 hours.

Inclusion criteria

  • age ≥18 years
  • mechanical ventilation expected for at least 48 hours

Exclusion criteria

Exclusion Criteria:

  • 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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
386 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 days after enrollment

Secondary outcomes

  1. 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.

    Time frame: first 7 days of ICU stay

  2. 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.

    Time frame: first 7 days ICU stay

06

Study locations

1 site
  • The University Hospital Brno
    Brno, Bohunice 62500, Czechia
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07280039
Lead sponsor
Brno University Hospital
Responsible party
Roman Gal (head of the department, Brno University Hospital) — Principal investigator
First posted
Dec 12, 2025
Start date
Dec 15, 2025 (estimated)
Primary completion
Dec 15, 2025 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Dec 12, 2025

Study contacts

Jana Fialová, M.D.
Contact
1149@fnbrno.cz
+42053322305
Roman Gal, M.D., PhD
study chair · Brno University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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