Muscle Mass Loss in Critically Ill Patients. | NCT03865095

Studies
Muscle Mass Loss in Critically Ill Patients.

NCT03865095

Sponsor

Masaryk University

Status

Completed

Last Update Posted

Mar 3, 2021Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Muscle Loss

Interventions

Not provided

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2019Actual

Primary Completion Date

Oct 14, 2020Actual

Completion Date

Nov 14, 2020Actual

First Submitted Date

Mar 5, 2019

First Submission Date that Met QC Criteria

Mar 5, 2019

First Posted Date

Mar 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2021

Last Update Posted Date

Mar 3, 2021Actual

Name	Class
Brno University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill adult patients admitted to intensive care unit with suspect length of artificial ventilation more than 48 hours.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roman Gal, M.D., PhD.	University Hospital Brno and Masaryk University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Brno and Masaryk University Brno		Brno		62500	Czechia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36639540	Derived	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.

ID	Term
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001284	Atrophy