Muscle Mass Loss in Critically Ill Patients.

Completed

• Conditions: Muscle Loss

• Registration Number: NCT03865095
• Lead Sponsor: Masaryk University

Brief Summary

The purpose of the study is to describe the change in muscle mass in critically ill patients. The study will examine rectus femoris cross sectional area with ultrasound and identify risk factors of this changes.

Detailed Description

The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of March 2019 to the 31st of August 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Ultrasound measurement of rectus femoris cross sectional area will be performed in first 24 hours after admission to ICU.

Study data will be entered in study form. The ultrasound measurement will be repeated on day 7 of hospitalisation.

Changes in rectus femoris cross sectional area and potential risk factors will be analysed. The length of ICU length of stay and 28-day mortality will be also monitored.

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Study Start: 2019-03-25
• Primary Completion: 2020-10-14
• Study Completion: 2020-11-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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
• age under 18 years
• inability to perform ultrasound examination
• death or discharge prior completion of protocol
• full verticalization prior completion of protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle mass loss	7 days	Change in cross sectional area of rectus femoris muscle estimated by ultrasound

Secondary Outcome Measures

Name	Time	Method
28 day mortality	28 days after enrolment	mortality 28 days after enrolment

Trial Locations

Locations (1)

University Hospital Brno and Masaryk University Brno; 🇨🇿 Brno, Czechia