Acute Infection RespiratoryNCT04223453
Body Composition Measurements in Pneumonia
An observational study of Acute Infection Respiratory, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial 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, Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Infection Respiratory
- What is being tested?
- BIA and DXA
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: X-ray verified acute pneumonia > 65 years of age
Who may be able to join
- Acute pneumonia,
- Accept participation (informed consent)
- Understand the given instructions and information
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Composition in Patients With Acute Pneumonia Measured by Bioimpedance and DXA
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,
Read the 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.
- Conditions
- Acute Infection Respiratory
- Being tested
- BIA and DXA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA and DXADiagnostic test
Patients with acute pneumonia measured simultaneously with DXA-scan and BIA-impedance
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between LBM (lean body mass) with DXA and BIA
At admittance both methods.
Measured: within 3 days
Secondary outcomes (2)
Development in lean-body-mass during hospital stay
Repeated measurement with BIA during the state of acute infection
Measured: 3-10 days (hospital stay)
BIA measured before and after oral glucose load test
To investigate for the effect of fasting on the determination of total body water with BIA
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start5 Jan 2019
- Primary completion17 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Infection RespiratoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Hillerod Hospital, Denmark
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R Andersen, MD,MPA, Principal investigator, University of Copenhagen, Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223453
- Sponsor's protocol ID
- Daniel1
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition in Patients With Acute Pneumonia Measured by Bioimpedance and DXA
- ClinicalTrials.gov ID
- NCT04223453
- Acronym / sponsor ID
- Daniel1
- Conditions
- Acute Infection Respiratory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- Hillerod Hospital, Denmark
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- X-ray verified acute pneumonia > 65 years of age
Key inclusion criteria (3 listed)
- Acute pneumonia,
- Accept participation (informed consent)
- Understand the given instructions and information
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIA and DXAPatients with acute pneumonia measured simultaneously with DXA-scan and BIA-impedance | Diagnostic test | – |
Primary outcome
Correlation between LBM (lean body mass) with DXA and BIA
Time frame: within 3 days
At admittance both methods.
2 secondary outcomes
Development in lean-body-mass during hospital stay
Time frame: 3-10 days (hospital stay)
BIA measured before and after oral glucose load test
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens R Andersen, MD,MPA principal investigator
University of Copenhagen, Department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Infection Respiratory, run by Jens Rikardt Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between LBM (lean body mass) with DXA and BIA (time frame: within 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.