- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03319329
Metabolic Determinants Of Resting Energy Expenditure Among Mechanically Ventilated Critically Ill Patients
Metabolic Determinants Of Resting Energy Expenditure Among Mechanically Ventilated Critically Ill Patients In Malaysian Tertiary Hospital
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pei Chien Tah
- Phone Number: 0163091880
- Email: pctah@ummc.edu.my
Study Contact Backup
- Name: Pei Chien Tah
- Email: pctah76@yahoo.com
Study Locations
-
-
Wilayah Persekutuan
-
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
- Recruiting
- University of Malaya Medical Centre
-
Contact:
- Pei Chien Tah
- Phone Number: 0163091880
- Email: pctah@ummc.edu.my
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 |
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
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
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
Sponsor
Investigators
- Principal Investigator: Pei Chien Tah, University of Malaya Medical Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20161024-4407
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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