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

NCT03319329 | Unknown

• 1 other identifier: 20161024-4407
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (8)

• The validity of several predictive equations by using Intraclass Correlation Coefficient (ICC) test

  24 months

• Determine metabolic determinants

  24 months

• The best regression equation model

  24 months

• Determine and compare REE measured by IC among mechanically ventilated critically ill patients

  24 months

• The association of REE in critically ill patients with clinical outcome

  24 months

Study Arms (1)

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

Device: Indirect Calorimetry

Interventions

Indirect Calorimetry 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.

critically ill adult patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients with mechanically ventilated

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

Related Publications (1)

• 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.

  PMID: 34462560 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Calorimetry, Indirect

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Pei Chien Tah

  UNIVERSITY OF MALAYA MEDICAL CENTRE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei Chien Tah

CONTACT

0163091880; pctah@ummc.edu.my

Pei Chien Tah

CONTACT

pctah76@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Faculty of Medicine

Study Record Dates

• First Submitted: September 23, 2017
• First Posted: October 24, 2017
• Study Start: February 13, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

MY (1)