NCT04223453

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,

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 7, 2020

Last Update Submit

January 8, 2020

Conditions

Acute Infection Respiratory

Outcome Measures

Primary Outcomes (1)

  • Correlation between LBM (lean body mass) with DXA and BIA

    At admittance both methods.

    within 3 days

Secondary Outcomes (2)

  • Development in lean-body-mass during hospital stay

    3-10 days (hospital stay)

  • BIA measured before and after oral glucose load test

    1 hour

Interventions

BIA and DXADIAGNOSTIC_TEST

Patients with acute pneumonia measured simultaneously with DXA-scan and BIA-impedance

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

X-ray verified acute pneumonia \> 65 years of age

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillerød Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jens R Andersen, MD,MPA

    University of Copenhagen, Department of Nutrition, Exercise and Sports

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 10, 2020

Study Start

January 5, 2019

Primary Completion

July 17, 2019

Study Completion

September 30, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)