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Metabolic Determinants Of Resting Energy Expenditure Among Mechanically Ventilated Critically Ill Patients

NCT ID: NCT03319329

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-13

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Indirect Calorimetry

Intervention Type DEVICE

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.

Interventions

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Indirect Calorimetry

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Tah Pei Chien

Department of Anesthesiology, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pei Chien Tah

Role: PRINCIPAL_INVESTIGATOR

UNIVERSITY OF MALAYA MEDICAL CENTRE

Locations

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University of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Pei Chien Tah

Role: CONTACT

Phone: 0163091880

Email: [email protected]

Pei Chien Tah

Role: CONTACT

Email: [email protected]

Facility Contacts

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Pei Chien Tah

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34462560 (View on PubMed)

Other Identifiers

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20161024-4407

Identifier Type: -

Identifier Source: org_study_id