Muscle Mass Loss in Critically Ill Patients.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03865095

Acronym

MUSIC

Enrollment

104

Registered

2019-03-06

Start date

2019-03-25

Completion date

2020-11-14

Last updated

2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Loss

Keywords

Critical Care, Muscle loss, Rectus femoris cross sectional area, Muscle ultrasound

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Muscle mass loss	7 days	Change in cross sectional area of rectus femoris muscle estimated by ultrasound

Secondary

Measure	Time frame	Description
28 day mortality	28 days after enrolment	mortality 28 days after enrolment

Countries

Czechia

Outcome results