NCT04500483

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

August 1, 2020

Last Update Submit

June 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • resting energy expenditure

    during the 7 days following injury in burn patients or following ICU discharge in ICU survivors

Study Arms (2)

Burn outpatients

Burn patients treated for minor burns in an outpatient setting

Diagnostic Test: indirect calorimetry

ICU survivors

Critically ill patients who survived ICU stay and are admitted in a general ward

Diagnostic Test: indirect calorimetry

Interventions

indirect calorimetryDIAGNOSTIC_TEST

measurement of resting energy expenditure using indirect calorimetry

Burn outpatientsICU survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • minor burn treated in an outpatient setting
  • ICU survivor, who was discharged from ICU after a stay of at least 7 days

You may not qualify if:

  • oxygen supply
  • chest drainage
  • not french speaking
  • confusion, coma
  • cognitive disorder
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

BurnsCritical IllnessNutrition Disorders

Condition Hierarchy (Ancestors)

Wounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutritional and Metabolic Diseases

Central Study Contacts

Anne-Françoise Rousseau, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

August 1, 2020

First Posted

August 5, 2020

Study Start

August 15, 2020

Primary Completion

August 15, 2023

Study Completion

August 15, 2025

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations