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Trial registered on ANZCTR
Registration number
ACTRN12621000007831
Ethics application status
Approved
Date submitted
22/10/2020
Date registered
8/01/2021
Date last updated
4/09/2023
Date data sharing statement initially provided
8/01/2021
Date results information initially provided
27/04/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
Measured energy expenditure in critically ill adult patients
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Scientific title
Measured energy expenditure in critically ill adult patients: a retrospective analysis of 10 years of indirect calorimetry data in an Australian Intensive Care Unit
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Secondary ID [1]
300912
0
Nil known.
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Universal Trial Number (UTN)
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Trial acronym
MEASURE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical illness
316849
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Condition category
Condition code
Diet and Nutrition
315051
315051
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0
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Other diet and nutrition disorders
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Public Health
317720
317720
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0
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Health service research
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Indirect calorimetry measures resting energy expenditure by quantifying inspired oxygen and expired carbon dioxide and is the recommended method of guiding energy provision in critically ill patients in key nutrition guidelines. However, indirect calorimetry is not widely available in Australia and there is minimal data describing measured energy expenditure during Intensive Care Unit (ICU) admission in a modern setting.
Study design: Retrospective single-centre observational study conducted at The Alfred ICU, Melbourne, Australia.
Population: Critically ill adult (=> 18 years) mechanically ventilated patients who had at least one indirect calorimetry measurement in the first 28 days of ICU admission at The Alfred between January 2010 to July 2019 will be considered for inclusion.
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Intervention code [1]
318369
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Not applicable
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Comparator / control treatment
Nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Measured energy expenditure (kcal and kcal/k/d), which is being collected from the indirect calorimetry device.
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Assessment method [1]
335971
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Timepoint [1]
335971
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During ICU admission
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Secondary outcome [1]
389239
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Measured energy expenditure (kcal and kcal/k/d), which is being collected from the indirect calorimetry device.
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Assessment method [1]
389239
0
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Timepoint [1]
389239
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Acute early (ICU day 1-2) phase of ICU admission
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Secondary outcome [2]
389240
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Measured energy expenditure (kcal and kcal/k/d), which is being collected from the indirect calorimetry device.
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Assessment method [2]
389240
0
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Timepoint [2]
389240
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Measured energy expenditure (kcal and kcal/k/d) as completed as part of routine clinical care (variable timepoint). This data is being collected from the indirect calorimetry device.
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Secondary outcome [3]
389241
0
Measured energy expenditure (kcal and kcal/k/d), which is being collected from the indirect calorimetry device.
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Assessment method [3]
389241
0
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Timepoint [3]
389241
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Recovery (>7 days) phase of illness of ICU admission
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Eligibility
Key inclusion criteria
Critically ill adult (=> 18 years) mechanically ventilated patients who had at least one indirect calorimetry measurement in the first 28 days of ICU admission at The Alfred between January 2010 to July 2019 will be considered for inclusion.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Indirect calorimetry measurements will be excluded if:
• The duration of measurement was <5 minutes;
• Measurements were conducted during treatment with therapeutic hypothermia or extracorporeal membrane oxygenation;
• The average respiratory quotient for the measurement was <0.67 or >1.3 or;
• The coefficient of variation (CV) for VO2 was >50%.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
Reporting of findings (including the primary outcome of energy expenditure in kcal/d and kcal/kg/d) will largely be descriptive using mean ± standard deviation or median [interquartile range] according to distribution. Accuracy of predictive equations will be defined as the number (%) of measurements between 90-110% of mEE. Predictive equations estimates <90% or >110% mEE will be considered to underestimate and overestimate measured energy expenditure, respectively. Bland-Altman plots will be used to display agreement between measured energy expenditure and predictive equations. For measured energy expenditure collected on multiple occasions per patient, repeated-measures mixed modelling will be used. Two subgroup analyses reporting energy expenditure according to key patient diagnoses and quality of indirect calorimetry measurements (low/medium and high-quality tests) will be performed using Student t-test or Mann-Whitney U test as appropriate for two-group comparisons and analysis of variance or Kruskal-Wallis test for comparisons involving more than two groups. Analysis will be performed using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA). A two-sided p-value of 0.05 will be used to indicate statistical significance.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
16/10/2018
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Date of last participant enrolment
Anticipated
31/07/2021
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Actual
31/07/2019
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Date of last data collection
Anticipated
31/07/2021
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Actual
3/05/2023
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Sample size
Target
800
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Accrual to date
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Final
629
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
17278
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
30991
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
305359
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University
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Name [1]
305359
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Monash University
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Address [1]
305359
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The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
AUSTRALIA
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Country [1]
305359
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Australia
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Primary sponsor type
Individual
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Name
Dr Emma Ridley
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Address
The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
AUSTRALIA
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Country
Australia
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Secondary sponsor category [1]
307015
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None
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Name [1]
307015
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Address [1]
307015
0
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Country [1]
307015
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305692
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The Alfred Ethics Committee
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Ethics committee address [1]
305692
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The Alfred
55 Commercial Rd, Melbourne VIC 3004
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Ethics committee country [1]
305692
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Australia
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Date submitted for ethics approval [1]
305692
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Approval date [1]
305692
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16/10/2018
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Ethics approval number [1]
305692
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531/18
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Ethics committee name [2]
306696
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Monash University Human Research Ethics Committee
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Ethics committee address [2]
306696
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Wellington Rd, Clayton VIC 3800
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Ethics committee country [2]
306696
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Australia
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Date submitted for ethics approval [2]
306696
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Approval date [2]
306696
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14/08/2020
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Ethics approval number [2]
306696
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26003
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Summary
Brief summary
Indirect calorimetry is a device used to measure energy requirements by measuring oxygen use and carbon dioxide production. Indirect calorimetry is the recommended method of guiding energy provision in critically ill patients in key nutrition guidelines. However, indirect calorimetry is not widely available in Australia and there is minimal data describing measured energy expenditure during Intensive Care Unit (ICU) admission in a modern setting.
The primary aim of this study is to describe measured energy expenditure in adult mechanically ventilated critically ill patients in a modern Australian ICU.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Emma Ridley
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Address
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The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
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Country
101246
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Australia
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Phone
101246
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+61 3 99030350
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Fax
101246
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Email
101246
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[email protected]
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Contact person for public queries
Name
101247
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Dr Emma Ridley
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Address
101247
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The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
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Country
101247
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Australia
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Phone
101247
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+61 3 99030350
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Fax
101247
0
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Email
101247
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[email protected]
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Contact person for scientific queries
Name
101248
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Dr Emma Ridley
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Address
101248
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The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
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Country
101248
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Australia
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Phone
101248
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+61 3 99030350
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Fax
101248
0
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Email
101248
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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