Muscle Mass Loss in Critically Ill Patients.

NCT ID: NCT03865095

Last Updated: 2021-03-03

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

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-11-14

Brief Summary

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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

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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.

Conditions

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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
* age under 18 years
* inability to perform ultrasound examination
* death or discharge prior completion of protocol
* full verticalization prior completion of protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brno University Hospital

OTHER

Sponsor Role collaborator

Masaryk University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roman Gal, M.D., PhD.

Role: STUDY_CHAIR

University Hospital Brno and Masaryk University

Locations

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University Hospital Brno and Masaryk University Brno

Brno, , Czechia

Site Status

Countries

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Czechia

References

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Hrdy O, Vrbica K, Kovar M, Korbicka T, Stepanova R, Gal R. Incidence of muscle wasting in the critically ill: a prospective observational cohort study. Sci Rep. 2023 Jan 13;13(1):742. doi: 10.1038/s41598-023-28071-8.

Reference Type DERIVED
PMID: 36639540 (View on PubMed)

Other Identifiers

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CT0012019

Identifier Type: -

Identifier Source: org_study_id

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