Mortality and Muscle Mass Loss in Critically Ill Patients.

NCT ID: NCT07280039

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

386 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-12-15

Brief Summary

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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

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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.

Conditions

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Mortality Muscle Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brno University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Roman Gal

head of the department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roman Gal, M.D., PhD

Role: STUDY_CHAIR

The University Hospital Brno

Locations

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The University Hospital Brno

Brno, Bohunice, Czechia

Site Status

Countries

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Czechia

Central Contacts

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Jana Fialová, M.D.

Role: CONTACT

+42053322305

Facility Contacts

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Jana Fialová, M.D.

Role: primary

+42053322305

Other Identifiers

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CT0022025

Identifier Type: -

Identifier Source: org_study_id

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