Muscle Mass and Body Composition | NCT03184623

Studies
Muscle Mass and Body Composition

NCT03184623

Sponsor

Frisius Medisch Centrum

Status

Completed

Last Update Posted

Sep 8, 2017Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Muscle Loss

Interventions

muscle mass measurement

Countries

Netherlands

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

Sep 2017

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

Jun 9, 2017Actual

Primary Completion Date

Sep 5, 2017Actual

Completion Date

Sep 5, 2017Actual

First Submitted Date

Jun 9, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 12, 2017Actual

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

Sep 5, 2017

Last Update Posted Date

Sep 8, 2017Actual

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

ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome.

Detailed Description

The weakness and disability that result from these neuromuscular disorders can dominate the lont-term course and impede recovery.

In this observational study we try to measure muscle mass and body composition by echocardiography and BIVA at admission and on day 2, 5

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

23Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
muscle mass measurement	Other	measurement of muscle mass by echocardiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in muscle mass measurements during ICU stay	measurement by echography	baseline, day 2 and day 5

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all acute admitted patients in ICU

Exclusion Criteria:

age < 18
stay on ICU < 48 hours
use of corticosteroids
neurological diseases
acute kidney injure / nead of CVVH

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

patients admitted to the ICU with an expected lenght of stay > 48 hours

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matty Koopmans, MSc	MCL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center Leeuwarden		Leeuwarden		8934AD	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009133	Muscular Atrophy

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided