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

October 22, 2017 updated by: Tah Pei Chien, University of Malaya

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
314

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
        • Recruiting
        • University of Malaya Medical Centre
        • Contact:
        • Sub-Investigator:
          • Mohd Shahnaz Bin Hasan
        • Sub-Investigator:
          • Vineya Rai Hakumat Rai
        • Sub-Investigator:
          • Bee Koon Poh
        • Sub-Investigator:
          • Mohd Basri Bin Mat Nor
        • Sub-Investigator:
          • Hazreen Bin Abdul Majid
        • Sub-Investigator:
          • Chee Cheong Kee
        • Sub-Investigator:
          • Mazuin Kamarul Zaman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Critically ill patients with mechanically ventilated

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The validity of several predictive equations by using Intraclass Correlation Coefficient (ICC) test
Time Frame: 24 months
predictive equations used to predict REE in critically ill adult patients among Malaysian population by using indirect calorimetry (IC) as the reference standard.
24 months
Determine metabolic determinants
Time Frame: 24 months
metabolic determinants that might influence resting energy expenditure among mechanically ventilated critically ill patients.
24 months
The best regression equation model
Time Frame: 24 months
Regression equation model for predicting energy requirement of mechanically ventilated critically ill patients.
24 months
Determine and compare REE measured by IC among mechanically ventilated critically ill patients
Time Frame: 24 months
during early phase (staying ≤ 5 days), late phase (staying 6-10 days) and chronic phase (staying > 10 days) in ICU.
24 months
The association of REE in critically ill patients with clinical outcome
Time Frame: 24 months
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.
24 months
The association of REE in critically ill patients with quality of life
Time Frame: 24 months
Questionnaire SF-36v2 Health Survey to measure quality of life for critically ill patients.
24 months
The association of REE in critically ill patients with nutrition risk
Time Frame: 24 months
NUTRIC score to quantify the nutrition risk of critically ill patients developing adverse events
24 months
The energy and protein adequacy in relation to patient outcome.
Time Frame: 24 months
Energy and protein adequacy in terms of Energy/Nitrogen ratio in relation to patient outcome.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pei Chien Tah, University of Malaya Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20161024-4407

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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