Clinical trial NCT03319329: Metabolic Determinants Of Resting Energy Expenditure Among Mechanically Ventilated Critically Ill Patients
Official title: Metabolic Determinants Of Resting Energy Expenditure Among Mechanically Ventilated Critically Ill Patients In Malaysian Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients with mechanically ventilated

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients aged over 18 years old
2. Critically ill patients with mechanically ventilated
3. Expected to have an ICU stay of more than 5 days
4. Patients had implemented for continuous enteral or parenteral nutrition support.

Exclusion Criteria:

1. Requirement for inspired oxygen content (FiO2) greater than 0.6
2. Patients on high frequency ventilation
3. Patients with chest tubes that leak air
4. Patients with incompetent tracheal cuff
5. Patients inhaled nitric oxide therapy
6. Patients receiving intermittent hemodialysis and continuous renal replacement therapy (CRRT) during IC measurement
7. Patients with pregnancy
8. Patients with burn injury
9. Patients infected with human immunodeficiency virus (HIV)
10. Patients with severe liver disease (Child-Pugh score C)
11. Patients with post open heart surgery
12. Patients with paraplegia and quadriplegia

Primary outcomes:
measure: Number of participants measured resting energy expenditure for the development of predictive equations
timeFrame: 24 months
Secondary outcomes:
measure: The validity of several predictive equations by using Intraclass Correlation Coefficient (ICC) test
timeFrame: 24 months
measure: Determine metabolic determinants
timeFrame: 24 months
measure: The best regression equation model
timeFrame: 24 months
measure: Determine and compare REE measured by IC among mechanically ventilated critically ill patients
timeFrame: 24 months
measure: The association of REE in critically ill patients with clinical outcome
timeFrame: 24 months
measure: The association of REE in critically ill patients with quality of life
timeFrame: 24 months
measure: The association of REE in critically ill patients with nutrition risk
timeFrame: 24 months
measure: The energy and protein adequacy in relation to patient outcome.
timeFrame: 24 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
state: Wilayah Persekutuan
Study officials:
affiliation: UNIVERSITY OF MALAYA MEDICAL CENTRE
name: Pei Chien Tah
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.