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NCT Number: NCT07280039

Mortality and Muscle Mass Loss in Critically Ill Patients.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Inability to perform ultrasound examination on day 7

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of a significant decrease in rectus femoris cross-sectional area

    Time frame: first 7 days of ICU stay

    A decrease in rectus femoris cross-sectional area of 10% or more measured by ultrasound.

  2. Incidence of an insignificant decrease in rectus femoris cross-sectional area

    Time frame: first 7 days ICU stay

    A decrease in rectus femoris cross-sectional area of less than 10% measured by ultrasound.

Study contacts

Contact information is provided by the study sponsor or research team.

Jana Fialová, M.D.

CONTACT

[email protected]

+42053322305

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

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

Acronym: MUSIC 2

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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