BurnsNCT04500483
Indirect Calorimetry in Patients at Risk of Malnutrition
An observational study of Burns and Critical Illness, run by University of Liege at 1 site in Belgium.
Trial summary
Burn patients treated in an outpatient clinic and ICU survivors are at risk of malnutrition. There are no clear guidelines determining the energy target in those two populations. The aim of this observation study is to measure the resting energy expenditure of those patients, using indirect calorimetry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Critical Illness, Indirect Calorimetry
- What is being tested?
- indirect calorimetry
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Aug 2020to 15 Aug 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the study population is divided into two groups: burn patients with minor burn exclusively treated in an outpatient setting, and ICU survivors who were discharged fro ICU after a stay of at least 7 days
Who may be able to join
- minor burn treated in an outpatient setting
- ICU survivor, who was discharged from ICU after a stay of at least 7 days
Who cannot join
- oxygen supply
- chest drainage
- not french speaking
- confusion, coma
- cognitive disorder
- patient refusal
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Liège
Liège, 4000
Anne-Françoise Rousseau, PhD, +3243667495, afrousseau@chuliege.be
About this study
Official title: Measurement of Resting Energy Expenditure in Burn or Critically Ill Patients at Risk of Malnutrition
Burn patients treated in an outpatient clinic and ICU survivors are at risk of malnutrition. There are no clear guidelines determining the energy target in those two populations. The aim of this observation study is to measure the resting energy expenditure of those patients, using indirect calorimetry.
- Conditions
- Burns, Critical Illness, Indirect Calorimetry, Resting Energy Expenditure, Nutrition Disorders
- Being tested
- indirect calorimetry
- Medical subject headings
- Burns, Critical Illness, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indirect calorimetryDiagnostic test
measurement of resting energy expenditure using indirect calorimetry
| Study group | Role | What they receive |
|---|---|---|
| Burn outpatients | Burn patients treated for minor burns in an outpatient setting Receives: Diagnostic Test: indirect calorimetry | |
| ICU survivors | Critically ill patients who survived ICU stay and are admitted in a general ward Receives: Diagnostic Test: indirect calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting energy expenditure
Measured: during the 7 days following injury in burn patients or following ICU discharge in ICU survivors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start15 Aug 2020
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Françoise Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500483
- Sponsor's protocol ID
- CaloIF
- Status last verified
- Jun 2023
- First submitted
- 1 Aug 2020
- Last updated
- 27 Jun 2023
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Resting Energy Expenditure in Burn or Critically Ill Patients at Risk of Malnutrition
- ClinicalTrials.gov ID
- NCT04500483
- Acronym / sponsor ID
- CaloIF
- Conditions
- Burns, Critical Illness, Indirect Calorimetry, Resting Energy Expenditure, Nutrition Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 5 Aug 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.
Burn patients treated in an outpatient clinic and ICU survivors are at risk of malnutrition. There are no clear guidelines determining the energy target in those two populations. The aim of this observation study is to measure the resting energy expenditure of those patients, using indirect calorimetry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burn outpatients | – | Diagnostic Test: indirect calorimetryBurn patients treated for minor burns in an outpatient setting |
| ICU survivors | – | Diagnostic Test: indirect calorimetryCritically ill patients who survived ICU stay and are admitted in a general ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study population is divided into two groups: burn patients with minor burn exclusively treated in an outpatient setting, and ICU survivors who were discharged fro ICU after a stay of at least 7 days
Key inclusion criteria (2 listed)
- minor burn treated in an outpatient setting
- ICU survivor, who was discharged from ICU after a stay of at least 7 days
Key exclusion criteria (6 listed)
- oxygen supply
- chest drainage
- not french speaking
- confusion, coma
- cognitive disorder
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 |
|---|---|---|
| indirect calorimetrymeasurement of resting energy expenditure using indirect calorimetry | Diagnostic test | Burn outpatients, ICU survivors |
Primary outcome
resting energy expenditure
Time frame: during the 7 days following injury in burn patients or following ICU discharge in ICU survivors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- 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.
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 Burns and Critical Illness, run by University of Liege at 1 site in Belgium.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Françoise Rousseau, MD, PhD (+3243667495, afrousseau@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting energy expenditure (time frame: during the 7 days following injury in burn patients or following ICU discharge in ICU survivors). 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 27 Jun 2023.