Basal Metabolic RateNCT07547865
Individualized Energy Expenditure Assessment in Critically Ill Patients
An observational study of Basal Metabolic Rate, run by Assiut University.
Trial summary
General objective To assess the role of indirect calorimetry in measuring energy expenditure and assess guided nutritional support among critically ill patients in the ICU. Specific Objectives 1. To assess the nutritional status of critically ill patients admitted to the ICU. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Metabolic Rate
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jan 2028
- Phase
- Observational
- 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
Study population: Critically ill patients
Who may be able to join
- - Adult patients (≥18 years).
- Patients who are hemodynamically stable at the time of measurement.
- Patients receiving nutritional support (enteral and/or parenteral).
Who cannot join
- - Patients with air leaks or high oxygen requirements interfering with indirect calorimetry measurements.
- Pregnant patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Individualized Energy Expenditure Assessment Using Indirect Calorimetry in Critically Ill Patients in Assiut University
General objective To assess the role of indirect calorimetry in measuring energy expenditure and assess guided nutritional support among critically ill patients in the ICU.
Specific Objectives
- To assess the nutritional status of critically ill patients admitted to the ICU.
- To measure energy requirements of critically ill patients using indirect calorimetry.
- To compare measured energy requirements obtained by indirect calorimetry with those estimated by predictive equations.
Read the detailed description
Human beings continuously exchange energy with their environment. All energy is derived from chemical substrates as carbohydrates, lipids, and proteins, liberated through oxidative metabolism into carbon dioxide and water, with a portion captured as adenosine triphosphate (ATP) for cellular functions [1].
Critically ill patients are characterized by catabolic stress status and inflammatory response, which may contribute to a variety of complications, including multi-organ failure, increased infectious morbidity, and prolonged hospitalization. It is challenging for patients in the intensive care unit (ICU) to acquire their nutritional requirements due to their critical health conditions, making it crucial to pay attention to their nutritional status, which is the key factor to improve their health outcomes and avoid associated complications [2] In critically ill patients, optimizing nutrition remains challenging, particularly regarding the quantity and timing of energy delivery. Early aggressive feeding to meet estimated energy expenditure (EE) was historically advocated to prevent malnutrition and muscle loss. However, randomized trials have not consistently shown benefit and have reported harm, including hyperglycemia, hepatic steatosis, and increased mortality [3]. Undernutrition remains common due to prescription inadequacies and failure to meet targets [3] Negative energy balance is associated with prolonged mechanical ventilation, infections, organ failure, longer hospital stay, and increased mortality [4]. Energy needs in critical illness are highly variable, influenced by disease severity, inflammation, sedation, mechanical ventilation, and individual metabolic responses, highlighting the need for individualized, real-time nutrition therapy [5-8].
Predictive equations, often derived from healthy populations and adjusted with stress factors, remain widely used but frequently misestimate EE, resulting in under- or overfeeding [8-10]. Indirect calorimetry (IC) provides a precise, real-time assessment of resting energy expenditure (REE) and substrate utilization by measuring oxygen consumption (VO₂) and carbon dioxide production (VCO₂). The respiratory quotient (RQ), defined as VCO₂/VO₂, indicates substrate oxidation, with 1.0 reflecting glucose and 0.7 mixed substrate utilization [5]. Current guidelines recommend IC as the preferred method to guide energy delivery in critically ill patients [8,12 ,13].
Advances in clinical calorimetry now allow accurate, user-friendly metabolic monitoring, enabling individualized energy and protein prescriptions. Evidence demonstrates that IC-guided nutrition improves outcomes, including morbidity and mortality, compared to equation-based estimates [13]. Critically, the benefit derives not from measurement alone but from tailoring nutrition support within a precision medicine framework.
Previous study done by Hamdan et al[2], found that the energy and protein intake of ICU patients was markedly below their estimated nutritional requirements, even that feeding was initiated early and maintained for a substantial period, overall intake remained inadequate. These observations align with previous reports highlighting persistent gaps in achieving nutritional targets in critically ill patients in many other countries And on the opposite sides, over feeding to ICU patients cause refeeding syndrome, with proven complications up to mortality[2,14,15,16] Despite clear evidence that both under- and overfeeding adversely affect critically ill patients, significant gaps remain in the practical application of individualized nutrition therapy. Most ICUs continue to rely on predictive equations, which are freqthoughuently inaccurate and fail to capture dynamic metabolic changes during critical illness. Although indirect calorimetry is recommended by international guidelines, its routine use is limited due to perceived complexity, cost, and lack of implementation strategies in everyday clinical practice. Moreover, the optimal timing and dose of energy and protein delivery, particularly during different phases of critical illness and post-ICU recovery, remain poorly defined. There is also limited evidence on how integrating IC-guided nutrition into precision medicine approaches impacts morbidity, length of ICU stay, and long-term functional outcomes [2,8,11,12].
- Conditions
- Basal Metabolic Rate
- Keywords
- nutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between energy expenditure measured by indirect calorimetry and predictive equations.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Metabolic RateStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ebrahim Mohammed Esmail, Assiut University
- Investigators
- Randa Mohamed Shams El-Deen, Professor, Study director, Professor of Public Health and Community Medicine Faculty of Medicine, Assiut UniversityMedhat Araby Khalil Saleh, Professor, Study director, Professor of Public Health and Community Medicine Faculty of Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547865
- Sponsor's protocol ID
- Energy Expenditure
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Energy Expenditure Assessment Using Indirect Calorimetry in Critically Ill Patients in Assiut University
- ClinicalTrials.gov ID
- NCT07547865
- Acronym / sponsor ID
- Energy Expenditure
- Conditions
- Basal Metabolic Rate
- Keywords
- nutrition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 23 Apr 2026 (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.
General objective To assess the role of indirect calorimetry in measuring energy expenditure and assess guided nutritional support among critically ill patients in the ICU.
Specific Objectives
- To assess the nutritional status of critically ill patients admitted to the ICU.
- To measure energy requirements of critically ill patients using indirect calorimetry.
- To compare measured energy requirements obtained by indirect calorimetry with those estimated by predictive equations.
Detailed description
Human beings continuously exchange energy with their environment. All energy is derived from chemical substrates as carbohydrates, lipids, and proteins, liberated through oxidative metabolism into carbon dioxide and water, with a portion captured as adenosine triphosphate (ATP) for cellular functions [1].
Critically ill patients are characterized by catabolic stress status and inflammatory response, which may contribute to a variety of complications, including multi-organ failure, increased infectious morbidity, and prolonged hospitalization. It is challenging for patients in the intensive care unit (ICU) to acquire their nutritional requirements due to their critical health conditions, making it crucial to pay attention to their nutritional status, which is the key factor to improve their health outcomes and avoid associated complications [2] In critically ill patients, optimizing nutrition remains challenging, particularly regarding the quantity and timing of energy delivery. Early aggressive feeding to meet estimated energy expenditure (EE) was historically advocated to prevent malnutrition and muscle loss. However, randomized trials have not consistently shown benefit and have reported harm, including hyperglycemia, hepatic steatosis, and increased mortality [3]. Undernutrition remains common due to prescription inadequacies and failure to meet targets [3] Negative energy balance is associated with prolonged mechanical ventilation, infections, organ failure, longer hospital stay, and increased mortality [4]. Energy needs in critical illness are highly variable, influenced by disease severity, inflammation, sedation, mechanical ventilation, and individual metabolic responses, highlighting the need for individualized, real-time nutrition therapy [5-8].
Predictive equations, often derived from healthy populations and adjusted with stress factors, remain widely used but frequently misestimate EE, resulting in under- or overfeeding [8-10]. Indirect calorimetry (IC) provides a precise, real-time assessment of resting energy expenditure (REE) and substrate utilization by measuring oxygen consumption (VO₂) and carbon dioxide production (VCO₂). The respiratory quotient (RQ), defined as VCO₂/VO₂, indicates substrate oxidation, with 1.0 reflecting glucose and 0.7 mixed substrate utilization [5]. Current guidelines recommend IC as the preferred method to guide energy delivery in critically ill patients [8,12 ,13].
Advances in clinical calorimetry now allow accurate, user-friendly metabolic monitoring, enabling individualized energy and protein prescriptions. Evidence demonstrates that IC-guided nutrition improves outcomes, including morbidity and mortality, compared to equation-based estimates [13]. Critically, the benefit derives not from measurement alone but from tailoring nutrition support within a precision medicine framework.
Previous study done by Hamdan et al[2], found that the energy and protein intake of ICU patients was markedly below their estimated nutritional requirements, even that feeding was initiated early and maintained for a substantial period, overall intake remained inadequate. These observations align with previous reports highlighting persistent gaps in achieving nutritional targets in critically ill patients in many other countries And on the opposite sides, over feeding to ICU patients cause refeeding syndrome, with proven complications up to mortality[2,14,15,16] Despite clear evidence that both under- and overfeeding adversely affect critically ill patients, significant gaps remain in the practical application of individualized nutrition therapy. Most ICUs continue to rely on predictive equations, which are freqthoughuently inaccurate and fail to capture dynamic metabolic changes during critical illness. Although indirect calorimetry is recommended by international guidelines, its routine use is limited due to perceived complexity, cost, and lack of implementation strategies in everyday clinical practice. Moreover, the optimal timing and dose of energy and protein delivery, particularly during different phases of critical illness and post-ICU recovery, remain poorly defined. There is also limited evidence on how integrating IC-guided nutrition into precision medicine approaches impacts morbidity, length of ICU stay, and long-term functional outcomes [2,8,11,12].
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (3 listed)
- - Adult patients (≥18 years).
- Patients who are hemodynamically stable at the time of measurement.
- Patients receiving nutritional support (enteral and/or parenteral).
Key exclusion criteria (2 listed)
- - Patients with air leaks or high oxygen requirements interfering with indirect calorimetry measurements.
- Pregnant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between energy expenditure measured by indirect calorimetry and predictive equations.
Time frame: one year
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 23 Apr 2026.
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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.
Randa Mohamed Shams El-Deen, Professor study director
Professor of Public Health and Community Medicine Faculty of Medicine, Assiut University
Medhat Araby Khalil Saleh, Professor study director
Professor of Public Health and Community Medicine Faculty of Medicine, Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Metabolic Rate, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Amira Ebrahim Mohammed, demonstrator (+201003601157, miro36117@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between energy expenditure measured by indirect calorimetry and predictive equations. (time frame: one year). 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 23 Apr 2026.