Critical IllnessIC-TEENCT07256340
Measuring Total Energy Expenditure in Critically Ill Patients Using the Doubly Labelled Water Method
A study testing DLW-based energy assessment in people with Critical Illness, run by Maastricht University Medical Center at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- DLW-based energy assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Admitted to the ICU of Jessa Hospital
- Male and female sexes
- Age: > 18 years old
- Expected ICU stay of 5 days or more
Who cannot join
- Dialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital Campus Virga Jesse
Hasselt, Limburg, 3500
Prof. Dr. Stessel, +3211 33 55 77, bjorn.stessel@jessazh.be
About this study
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.
- Conditions
- Critical Illness
- Being tested
- DLW-based energy assessment
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLW-based energy assessmentDiagnostic test
Measuring TEE in IC patients with DLW
| Study group | Role | What they receive |
|---|---|---|
| DLW-based energy assessment | Experimental | Single-arm observational study Receives: Diagnostic Test: DLW-based energy assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Measured using the DLW method by only taking urine samples
Measured: Min: 1-5 days; Max: 1-20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a prospective, interventional trial with a single group design.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256340
- Sponsor's protocol ID
- 2025/108
- Acronym
- IC-TEE
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Total Energy Expenditure in Critically Ill Patients Using the Doubly Labelled Water Method
- ClinicalTrials.gov ID
- NCT07256340
- Acronym / sponsor ID
- IC-TEE / 2025/108
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Dec 2025 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, interventional trial with a single group design.
| Arm | Type | Receives |
|---|---|---|
| DLW-based energy assessment | Experimental | Diagnostic Test: DLW-based energy assessmentSingle-arm observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to the ICU of Jessa Hospital
- Male and female sexes
- Age: > 18 years old
- Expected ICU stay of 5 days or more
Key exclusion criteria (1 listed)
- Dialysis
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 |
|---|---|---|
| DLW-based energy assessmentMeasuring TEE in IC patients with DLW | Diagnostic test | DLW-based energy assessment |
Primary outcome
Energy expenditure
Time frame: Min: 1-5 days; Max: 1-20 days
Measured using the DLW method by only taking urine samples
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLW-based energy assessment in people with Critical Illness, run by Maastricht University Medical Center 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 4 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michèlle Hendriks (+31 43 388 1184, michelle.hendriks@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (time frame: Min: 1-5 days; Max: 1-20 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 Dec 2025.