Mortality and Muscle Mass Loss in Critically Ill Patients.

NCT07280039 | Not Yet Recruiting

• 1 other identifier: CT0022025
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 1

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.

Conditions

Mortality; Muscle Loss

Keywords

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

Outcome Measures

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.

  28 days after enrollment

Secondary Outcomes (2)

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

  first 7 days of ICU stay

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

  first 7 days ICU stay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

The University Hospital Brno

Brno, Bohunice, 62500, Czechia

Location

MeSH Terms

Conditions

Muscular Atrophy; Critical Illness

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Roman Gal, M.D., PhD

  The University Hospital Brno

  STUDY CHAIR

Central Study Contacts

Jana Fialová, M.D.

CONTACT

+42053322305; 1149@fnbrno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of the department

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: December 15, 2025
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)