Mortality and Muscle Mass Loss in Critically Ill Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mortality, Muscle Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mortality and Muscle Mass Loss in Critically Ill Patients: A Prospective, Observational, Multicenter Study.
Overview
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.
Primary outcome measures
- Relationship between muscle loss and 28 day mortality [Time frame: 28 days after enrollment]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Czechia · 1 center
- The University Hospital Brno — Brno
Identifiers
NCT: NCT07280039 · CT0022025