- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07256340
Measuring Total Energy Expenditure in Critically Ill Patients Using the Doubly Labelled Water Method (IC-TEE)
Critically ill patients, such as those with trauma or sepsis, experience high rates of malnutrition (up to 75%). Malnutrition worsens outcomes by increasing infection rates, hospital stays, mortality, and healthcare costs. Adequate nutrition is therefore crucial in the ICU. To ensure appropriate nutrition, accurate determination of total energy expenditure (TEE) is essential. In practice, predictive equations are often used, but these can misestimate TEE in ICU patients due to complex metabolic changes. Indirect calorimetry is recommended but limited by technical constraints. Consequently, the doubly labeled water (DLW) method, though expensive, offers a precise and non-invasive way to measure TEE over time.
This study applies the DLW method in ICU patients to improve energy assessment and guide personalized nutrition strategies that support recovery and outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michèlle Hendriks
- Phone Number: +31 43 388 1184
- Email: michelle.hendriks@maastrichtuniversity.nl
Study Locations
-
-
Limburg
-
Hasselt, Limburg, Belgium, 3500
- Recruiting
- Jessa Hospital Campus Virga Jesse
-
Contact:
- Prof. Dr. Stessel
- Phone Number: +3211 33 55 77
- Email: bjorn.stessel@jessazh.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Admitted to the ICU of Jessa Hospital
- Male and female sexes
- Age: > 18 years old
- Expected ICU stay of 5 days or more
Exclusion Criteria:
- Dialysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DLW-based energy assessment
Single-arm observational study
|
Measuring TEE in IC patients with DLW
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy expenditure
Time Frame: Min: 1-5 days; Max: 1-20 days
|
Measured using the DLW method by only taking urine samples
|
Min: 1-5 days; Max: 1-20 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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