NCT03865095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

March 5, 2019

Last Update Submit

March 2, 2021

Conditions

Muscle Loss

Keywords

Critical CareMuscle lossRectus femoris cross sectional areaMuscle ultrasound

Outcome Measures

Primary Outcomes (1)

  • Muscle mass loss

    Change in cross sectional area of rectus femoris muscle estimated by ultrasound

    7 days

Secondary Outcomes (1)

  • 28 day mortality

    28 days after enrolment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brno and Masaryk University Brno

Brno, 62500, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 36639540DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Roman Gal, M.D., PhD.

    University Hospital Brno and Masaryk University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 6, 2019

Study Start

March 25, 2019

Primary Completion

October 14, 2020

Study Completion

November 14, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)