Critical IllnessNCT07024264
Measured Versus Estimated Energy Requirement in the ICU Patients
An observational study of Critical Illness and Energy Requirement, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
The goal of this observational study is to compare energy requirements estimated by predictive equation and indirect calorimetry across different BMI categories, and to examine how these estimates, along with early nutritional strategies and progressive caloric delivery relate to ICU outcomes. Read more about this study
- Who is it for?
- Ages 20 to 105 years
- Conditions the study is for
- Critical Illness, Energy Requirement, Equation
- What is being tested?
- Total energy requirement calculated by predictive equation
- How many people
- 133 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2022to 31 Mar 2024
- 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 20 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to ICU and ventilator dependent in Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare.
Who may be able to join
- Length of ICU stay > 4 days
- Mechanically ventilated adults (>20 y/o)
- Tube feeding
- At high risk of malnutrition by Global Leadership Initiative on Malnutrition (GLIM) criteria: underweight and obesity
- Doctor's preference: cachexia, hypermetabolic status, TPN etc.,…
Who cannot join
- Length of ICU stay <4 days
- Mechanically ventilated adults (<=20 y/o)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City
About this study
Official title: Caloric Estimation Using Predictive Equations and Indirect Calorimetry in ICU Patients
The goal of this observational study is to compare energy requirements estimated by predictive equation and indirect calorimetry across different BMI categories, and to examine how these estimates, along with early nutritional strategies and progressive caloric delivery relate to ICU outcomes. The main questions it aims to answer are:
- To evaluate whether predictive equation and/or indirect calorimetry provides accurate caloric targets in critically ill patients.
- To identify high-risk malnutrition patients (underweight, normal and overweight, obese) who may benefit most from IC-based measurement.
- To investigate the impact of caloric strategies and nutritional achievement during the acute phase on the length of ICU stay.
- Being tested
- Total energy requirement calculated by predictive equation
- Medical subject headings
- Critical Illness, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total energy requirement calculated by predictive equationOther
Critically ill patients are highly susceptible to malnutrition, making accurate caloric estimation essential to prevent both underfeeding and overfeeding during the acute phase in the ICU. Although predictive equations (PE) are widely used to estimate energy requirement, indirect calorimetry (IC) remains the gold standard. This study aimed to compare energy requirements estimated by PE and IC across different BMI categories.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was ICU length of stay.
This study aimed to compare energy requirements estimated by PE and IC across different BMI categories, and to examine how these estimates, along with early nutritional strategies and progressive caloric delivery relate to the length of ICU stay.
Measured: From admitted to ICU which defined as day 1, until transferred to the general wards or expired, up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Oct 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024264
- Sponsor's protocol ID
- N202409050
- Status last verified
- Oct 2024
- First submitted
- 14 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available.
PubMed 26773077Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
PubMed 30348463De Waele E, Jonckheer J, Wischmeyer PE. Indirect calorimetry in critical illness: a new standard of care? Curr Opin Crit Care. 2021 Aug 1;27(4):334-343. doi: 10.1097/MCC.0000000000000844.
PubMed 33990505Zusman O, Theilla M, Cohen J, Kagan I, Bendavid I, Singer P. Resting energy expenditure, calorie and protein consumption in critically ill patients: a retrospective cohort study. Crit Care. 2016 Nov 10;20(1):367. doi: 10.1186/s13054-016-1538-4.
PubMed 27832823
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caloric Estimation Using Predictive Equations and Indirect Calorimetry in ICU Patients
- ClinicalTrials.gov ID
- NCT07024264
- Acronym / sponsor ID
- N202409050
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 17 Jun 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.
The goal of this observational study is to compare energy requirements estimated by predictive equation and indirect calorimetry across different BMI categories, and to examine how these estimates, along with early nutritional strategies and progressive caloric delivery relate to ICU outcomes. The main questions it aims to answer are:
- To evaluate whether predictive equation and/or indirect calorimetry provides accurate caloric targets in critically ill patients.
- To identify high-risk malnutrition patients (underweight, normal and overweight, obese) who may benefit most from IC-based measurement.
- To investigate the impact of caloric strategies and nutritional achievement during the acute phase on the length of ICU stay.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU and ventilator dependent in Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare.
Key inclusion criteria (5 listed)
- Length of ICU stay > 4 days
- Mechanically ventilated adults (>20 y/o)
- Tube feeding
- At high risk of malnutrition by Global Leadership Initiative on Malnutrition (GLIM) criteria: underweight and obesity
- Doctor's preference: cachexia, hypermetabolic status, TPN etc.,…
Key exclusion criteria (2 listed)
- Length of ICU stay <4 days
- Mechanically ventilated adults (<=20 y/o)
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 |
|---|---|---|
| Total energy requirement calculated by predictive equationCritically ill patients are highly susceptible to malnutrition, making accurate caloric estimation essential to prevent both underfeeding and overfeeding during the acute phase in the ICU. Although predictive equations (PE) are widely used to estimate energy requirement, indirect calorimetry (IC) remains the gold standard. This study aimed to compare energy requirements estimated by PE and IC across different BMI categories. | Other | – |
Primary outcome
The primary outcome was ICU length of stay.
Time frame: From admitted to ICU which defined as day 1, until transferred to the general wards or expired, up to 12 weeks.
This study aimed to compare energy requirements estimated by PE and IC across different BMI categories, and to examine how these estimates, along with early nutritional strategies and progressive caloric delivery relate to the length of ICU stay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Background: PubMed 26773077McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available.
- Background: PubMed 30348463Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
- Background: PubMed 33990505De Waele E, Jonckheer J, Wischmeyer PE. Indirect calorimetry in critical illness: a new standard of care? Curr Opin Crit Care. 2021 Aug 1;27(4):334-343. doi: 10.1097/MCC.0000000000000844.
- Background: PubMed 27832823Zusman O, Theilla M, Cohen J, Kagan I, Bendavid I, Singer P. Resting energy expenditure, calorie and protein consumption in critically ill patients: a retrospective cohort study. Crit Care. 2016 Nov 10;20(1):367. doi: 10.1186/s13054-016-1538-4.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Critical Illness and Energy Requirement, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 17 Jun 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was ICU length of stay. (time frame: From admitted to ICU which defined as day 1, until transferred to the general wards or expired, up to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07024264, which also lists 4 linked publications.
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 17 Jun 2025.