Body Composition Measurements in Pneumonia | NCT04223453

Studies
Body Composition Measurements in Pneumonia

NCT04223453

Sponsor

Jens Rikardt Andersen

Status

Completed

Last Update Posted

Jan 10, 2020Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Acute Infection Respiratory

Interventions

BIA and DXA

Countries

Denmark

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

Jan 2020

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

Jan 5, 2019Actual

Primary Completion Date

Jul 17, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Jan 7, 2020

First Submission Date that Met QC Criteria

Jan 8, 2020

First Posted Date

Jan 10, 2020Actual

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

Jan 8, 2020

Last Update Posted Date

Jan 10, 2020Actual

Name	Class
Hillerod Hospital, Denmark	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 this study is to validate and standardize bioelectrical impedance analysis (BIA, Maltron BioScan touch i8) for estimating body composition in hospitalized elderly patients with pneumonia. Body composition assessments with BIA and dual-energy x-ray absorptiometry (DXA,

Detailed Description

Holigic Discovery) was performed on 36 non-fasting patients over 65 years of age. 29 patients had BIA performed within 24 hours after hospital admission and at the date of discharge. 17 patients had BIA performed in fasted state and one hour after an intake of 300 ml glucose solution.

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

36Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIA and DXA	Diagnostic Test	Patients with acute pneumonia measured simultaneously with DXA-scan and BIA-impedance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between LBM (lean body mass) with DXA and BIA	At admittance both methods.	within 3 days

Secondary Outcomes

Measure	Description	Time Frame
Development in lean-body-mass during hospital stay	Repeated measurement with BIA during the state of acute infection	3-10 days (hospital stay)
BIA measured before and after oral glucose load test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute pneumonia,
Accept participation (informed consent)
Understand the given instructions and information

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

X-ray verified acute pneumonia > 65 years of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens R Andersen, MD,MPA	University of Copenhagen, Department of Nutrition, Exercise and Sports	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillerød Hospital		Hillerød		3400	Denmark

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

Intervention Browse Module

MeSH Terms

ID	Term
D015502	Absorptiometry, Photon

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

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