Muscle Mass Loss in Critically Ill Patients.

Muscle Loss Clinical Trial

— MUSIC  

Official title:

Muscle Mass Loss in Critically Ill and Its Risk Factors. A Prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03865095
• Other study ID #: CT0012019
• Status: Completed
• Start date: March 25, 2019
• Est. completion date: November 14, 2020

Study information

• Verified date: March 2021
• Source: Masaryk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Muscle Loss

Locations

Country	Name	City	State
Czechia	University Hospital Brno and Masaryk University Brno	Brno

Sponsors (2)

Lead Sponsor	Collaborator
Masaryk University	Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass loss	Change in cross sectional area of rectus femoris muscle estimated by ultrasound	7 days
Secondary	28 day mortality	mortality 28 days after enrolment	28 days after enrolment