Critical IllnessNCT03319329
Metabolic Determinants Of Resting Energy Expenditure Among Mechanically Ventilated Critically Ill Patients
An observational study of Critical Illness, run by University of Malaya at 1 site in Malaysia.
Trial summary
Currently there are no study related to Indirect Calorimetry (IC) has been done among hospitalised Malaysian ICU adult patients with its racial mix. The aim of this study is to perform a cross-sectional study in Malaysian critically ill patients to determine metabolic determinants that might influence resting energy… 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?
- Indirect Calorimetry
- Type of treatment
- Medical device
- How many people
- 314 participants
- Where
- 1 siteMalaysia
- Study dates
- 13 Feb 2017to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients with mechanically ventilated
Who may be able to join
- Adult patients aged over 18 years old
- Critically ill patients with mechanically ventilated
- Expected to have an ICU stay of more than 5 days
- Patients had implemented for continuous enteral or parenteral nutrition support.
Who cannot join
- Requirement for inspired oxygen content (FiO2) greater than 0.6
- Patients on high frequency ventilation
- Patients with chest tubes that leak air
- Patients with incompetent tracheal cuff
- Patients inhaled nitric oxide therapy
- Patients receiving intermittent hemodialysis and continuous renal replacement therapy (CRRT) during IC measurement
Show all 12Show fewer
- Patients with pregnancy
- Patients with burn injury
- Patients infected with human immunodeficiency virus (HIV)
- Patients with severe liver disease (Child-Pugh score C)
- Patients with post open heart surgery
- Patients with paraplegia and quadriplegia
Trial locations and contacts
1 site in 1 country.
Pei Chien Tah contact
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Pei Chien Tah, 0163091880, pctah@ummc.edu.my
Mohd Shahnaz Bin Hasan
About this study
Official title: Metabolic Determinants Of Resting Energy Expenditure Among Mechanically Ventilated Critically Ill Patients In Malaysian Tertiary Hospital
Currently there are no study related to Indirect Calorimetry (IC) has been done among hospitalised Malaysian ICU adult patients with its racial mix. The aim of this study is to perform a cross-sectional study in Malaysian critically ill patients to determine metabolic determinants that might influence resting energy expenditure (REE) and to develop predictive equation for the estimation of energy requirement using the regression based approach to increase the accuracy in calorie prescriptions. In addition, expected outcome of this study is to determine which equations have clinical usefulness among Malaysian adult critically ill patients and hope to introduce into routine clinical practice in the future if IC is not available.
Read the detailed description
Nutrition provision in the clinical setting relies heavily on the accurate estimation of energy and protein requirements. This can be done in a quick and inexpensive manner via the use of predictive equations. Some of the most popularly used predictive equations such as the Harris-Benedict equation and the Mifflin-St. Jeor equation have been widely applied within the clinical setting to estimate energy requirements among mechanically ventilated critically ill patients. However, these existing equations were not specially developed for a population with disease, as the equations were derived from a pool of healthy Caucasian adults. In addition, most of the equations for critically ill patients such as the Penn State equation, Faisy equation and Raurich Equation developed and validated among Caucasian in western country and not among Asian population. Therefore, their accuracy in predicting energy requirement is questionable when applied within Malaysian mechanically ventilated critically ill patients with its racial mix.
- Conditions
- Critical Illness
- Being tested
- Indirect Calorimetry
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimetryDevice
REE measurements were using IC (Cosmed, Quark RMR 2.0, Indirect Calorimetry Lab, Italy). A standard protocol for conducting the measurement was followed (Schlein \& Coulter, 2014);(P. Singer \& Singer, 2016); (Taku Oshima et al., 2016). Before each measurement, the metabolic monitor was allowed to warm up for 30 min, and then gas and flowmeter calibrations were performed by an experienced dietitian or healthcare professional. The REE was recorded after a 30 min non-fasting steady state according to RMR protocol and manufacturer instructions.
| Study group | Role | What they receive |
|---|---|---|
| critically ill adult patients | Part I: A cross-sectional study to compare validity of several predictive equations used to predict REE in critically ill adult patients for staying ≤ 5 days, 6 - 10 days and > 10 days by using indirect calorimetry (IC) as the reference standard.
Part II: To develop predictive equation for the estimation of energy requirement by identifying variables that might influence REE of mechanically ventilated critically ill patients.
Part III: To validate the newly developed predictive equation for the estimation of energy requirement by using Ten fold cross-validation approach Receives: Device: Indirect Calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants measured resting energy expenditure for the development of predictive equations
predictive equations for the estimation of energy requirement among mechanically ventilated critically ill patients among Malaysian population.
Measured: 24 months
Secondary outcomes (8)
The validity of several predictive equations by using Intraclass Correlation Coefficient (ICC) test
predictive equations used to predict REE in critically ill adult patients among Malaysian population by using indirect calorimetry (IC) as the reference standard.
Measured: 24 months
Determine metabolic determinants
metabolic determinants that might influence resting energy expenditure among mechanically ventilated critically ill patients.
Measured: 24 months
The best regression equation model
Regression equation model for predicting energy requirement of mechanically ventilated critically ill patients.
Measured: 24 months
Determine and compare REE measured by IC among mechanically ventilated critically ill patients
during early phase (staying ≤ 5 days), late phase (staying 6-10 days) and chronic phase (staying > 10 days) in ICU.
Measured: 24 months
The association of REE in critically ill patients with clinical outcome
Clinical outcome are hospital mortality and ICU mortality in 28 days and 60 days, length of mechanical ventilation in hours, duration of ICU stay in days and infectious complications such as Hospital acquired infection.
Measured: 24 months
The association of REE in critically ill patients with quality of life
Questionnaire SF-36v2 Health Survey to measure quality of life for critically ill patients.
Measured: 24 months
The association of REE in critically ill patients with nutrition risk
NUTRIC score to quantify the nutrition risk of critically ill patients developing adverse events
Measured: 24 months
The energy and protein adequacy in relation to patient outcome.
Energy and protein adequacy in terms of Energy/Nitrogen ratio in relation to patient outcome.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start13 Feb 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tah Pei Chien, University of Malaya
- Investigators
- Pei Chien Tah, Principal investigator, UNIVERSITY OF MALAYA MEDICAL CENTRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319329
- Sponsor's protocol ID
- 20161024-4407
- Status last verified
- Oct 2017
- First submitted
- 23 Sep 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tah PC, Poh BK, Kee CC, Lee ZY, Hakumat-Rai VR, Mat Nor MB, Kamarul Zaman M, Majid HA, Hasan MS. Do we need different predictive equations for the acute and late phases of critical illness? A prospective observational study with repeated indirect calorimetry measurements. Eur J Clin Nutr. 2022 Apr;76(4):527-534. doi: 10.1038/s41430-021-00999-y. Epub 2021 Aug 30.
PubMed 34462560
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Determinants Of Resting Energy Expenditure Among Mechanically Ventilated Critically Ill Patients In Malaysian Tertiary Hospital
- ClinicalTrials.gov ID
- NCT03319329
- Acronym / sponsor ID
- 20161024-4407
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Oct 2017 (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.
Currently there are no study related to Indirect Calorimetry (IC) has been done among hospitalised Malaysian ICU adult patients with its racial mix. The aim of this study is to perform a cross-sectional study in Malaysian critically ill patients to determine metabolic determinants that might influence resting energy expenditure (REE) and to develop predictive equation for the estimation of energy requirement using the regression based approach to increase the accuracy in calorie prescriptions. In addition, expected outcome of this study is to determine which equations have clinical usefulness among Malaysian adult critically ill patients and hope to introduce into routine clinical practice in the future if IC is not available.
Detailed description
Nutrition provision in the clinical setting relies heavily on the accurate estimation of energy and protein requirements. This can be done in a quick and inexpensive manner via the use of predictive equations. Some of the most popularly used predictive equations such as the Harris-Benedict equation and the Mifflin-St. Jeor equation have been widely applied within the clinical setting to estimate energy requirements among mechanically ventilated critically ill patients. However, these existing equations were not specially developed for a population with disease, as the equations were derived from a pool of healthy Caucasian adults. In addition, most of the equations for critically ill patients such as the Penn State equation, Faisy equation and Raurich Equation developed and validated among Caucasian in western country and not among Asian population. Therefore, their accuracy in predicting energy requirement is questionable when applied within Malaysian mechanically ventilated critically ill patients with its racial mix.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill adult patients | – | Device: Indirect CalorimetryPart I: A cross-sectional study to compare validity of several predictive equations used to predict REE in critically ill adult patients for staying ≤ 5 days, 6 - 10 days and > 10 days by using indirect calorimetry (IC) as the reference standard. Part II: To develop predictive equation for the estimation of energy requirement by identifying variables that might influence REE of mechanically ventilated critically ill patients. Part III: To validate the newly developed predictive equation for the estimation of energy requirement by using Ten fold cross-validation approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with mechanically ventilated
Key inclusion criteria (4 listed)
- Adult patients aged over 18 years old
- Critically ill patients with mechanically ventilated
- Expected to have an ICU stay of more than 5 days
- Patients had implemented for continuous enteral or parenteral nutrition support.
Key exclusion criteria (12 listed)
- Requirement for inspired oxygen content (FiO2) greater than 0.6
- Patients on high frequency ventilation
- Patients with chest tubes that leak air
- Patients with incompetent tracheal cuff
- Patients inhaled nitric oxide therapy
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 |
|---|---|---|
| Indirect CalorimetryREE measurements were using IC (Cosmed, Quark RMR 2.0, Indirect Calorimetry Lab, Italy). A standard protocol for conducting the measurement was followed (Schlein \& Coulter, 2014);(P. Singer \& Singer, 2016); (Taku Oshima et al., 2016). Before each measurement, the metabolic monitor was allowed to warm up for 30 min, and then gas and flowmeter calibrations were performed by an experienced dietitian or healthcare professional. The REE was recorded after a 30 min non-fasting steady state according to RMR protocol and manufacturer instructions. | Device | critically ill adult patients |
Primary outcome
Number of participants measured resting energy expenditure for the development of predictive equations
Time frame: 24 months
predictive equations for the estimation of energy requirement among mechanically ventilated critically ill patients among Malaysian population.
8 secondary outcomes
The validity of several predictive equations by using Intraclass Correlation Coefficient (ICC) test
Time frame: 24 months
Determine metabolic determinants
Time frame: 24 months
The best regression equation model
Time frame: 24 months
Determine and compare REE measured by IC among mechanically ventilated critically ill patients
Time frame: 24 months
The association of REE in critically ill patients with clinical outcome
Time frame: 24 months
The association of REE in critically ill patients with quality of life
Time frame: 24 months
The association of REE in critically ill patients with nutrition risk
Time frame: 24 months
The energy and protein adequacy in relation to patient outcome.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Derived from this study: PubMed 34462560Tah PC, Poh BK, Kee CC, Lee ZY, Hakumat-Rai VR, Mat Nor MB, Kamarul Zaman M, Majid HA, Hasan MS. Do we need different predictive equations for the acute and late phases of critical illness? A prospective observational study with repeated indirect calorimetry measurements. Eur J Clin Nutr. 2022 Apr;76(4):527-534. doi: 10.1038/s41430-021-00999-y. Epub 2021 Aug 30.
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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. This study is not recruiting at the moment.
Pei Chien Tah contact
Pei Chien Tah principal investigator
UNIVERSITY OF MALAYA MEDICAL CENTRE
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, run by University of Malaya at 1 site in Malaysia.
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 12 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: status not confirmed, as of the sponsor's last update on 24 Oct 2017. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei Chien Tah (0163091880, pctah@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants measured resting energy expenditure for the development of predictive equations (time frame: 24 months). 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 NCT03319329, which also lists 1 linked publication.
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 24 Oct 2017.