Mortality and Muscle Mass Loss in Critically Ill Patients.

Mortality and Muscle Mass Loss in Critically Ill Patients: A Prospective, Observational, Multicenter Study.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07280039

Acronym

MUSIC 2

Enrollment

386

Registered

2025-12-12

Start date

2025-12-15

Completion date

2026-12-15

Last updated

2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mortality, Muscle Loss

Keywords

Mortality, Muscle loss, Muscle ultrasound, Critically ill, Rectus femoris cross area

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame	Description
Relationship between muscle loss and 28 day mortality	28 days after enrollment	Critically ill patients with a ≥10% decrease in rectus femoris cross-sectional area have increased 28 day mortality.

Secondary

Measure	Time frame	Description
Incidence of a significant decrease in rectus femoris cross-sectional area	first 7 days of ICU stay	A decrease in rectus femoris cross-sectional area of 10% or more measured by ultrasound.
Incidence of an insignificant decrease in rectus femoris cross-sectional area	first 7 days ICU stay	A decrease in rectus femoris cross-sectional area of less than 10% measured by ultrasound.

Countries

Czechia

Contacts

Primary ContactJana Fialová, M.D.

1149@fnbrno.cz+42053322305

Outcome results