Indirect Calorimetry in Patients at Risk of Malnutrition | NCT04500483

Studies
Indirect Calorimetry in Patients at Risk of Malnutrition

NCT04500483

Sponsor

University of Liege

Status

Unknown status

Last Update Posted

Jun 27, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Burns
Critical Illness
Indirect Calorimetry
Resting Energy Expenditure
Nutrition Disorders

Interventions

indirect calorimetry

Countries

Belgium

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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2020Actual

Primary Completion Date

Aug 15, 2023Estimated

Completion Date

Aug 15, 2025Estimated

First Submitted Date

Aug 1, 2020

First Submission Date that Met QC Criteria

Aug 1, 2020

First Posted Date

Aug 5, 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

Jun 25, 2023

Last Update Posted Date

Jun 27, 2023Actual

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

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.

Detailed Description

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
indirect calorimetry	Diagnostic Test	measurement of resting energy expenditure using indirect calorimetry	Burn outpatients ICU survivors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
resting energy expenditure		during the 7 days following injury in burn patients or following ICU discharge in ICU survivors

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne-Françoise Rousseau, MD, PhD	Contact	+3243667495		afrousseau@chuliege.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Liège	Recruiting	Liège		4000	Belgium

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

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D016638	Critical Illness
D009748	Nutrition Disorders

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided