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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
Type of registration
Retrospectively registered

Titles & IDs
Public title
Measured energy expenditure in critically ill adult patients
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
Secondary ID [1] 300912 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
MEASURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 316849 0
Condition category
Condition code
Diet and Nutrition 315051 315051 0 0
Other diet and nutrition disorders
Public Health 317720 317720 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 318369 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335971 0
Measured energy expenditure (kcal and kcal/k/d), which is being collected from the indirect calorimetry device.
Timepoint [1] 335971 0
During ICU admission
Secondary outcome [1] 389239 0
Measured energy expenditure (kcal and kcal/k/d), which is being collected from the indirect calorimetry device.
Timepoint [1] 389239 0
Acute early (ICU day 1-2) phase of ICU admission
Secondary outcome [2] 389240 0
Measured energy expenditure (kcal and kcal/k/d), which is being collected from the indirect calorimetry device.
Timepoint [2] 389240 0
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.
Secondary outcome [3] 389241 0
Measured energy expenditure (kcal and kcal/k/d), which is being collected from the indirect calorimetry device.
Timepoint [3] 389241 0
Recovery (>7 days) phase of illness of ICU admission

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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%.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/10/2018
Date of last participant enrolment
Anticipated
31/07/2021
Actual
31/07/2019
Date of last data collection
Anticipated
31/07/2021
Actual
3/05/2023
Sample size
Target
800
Accrual to date
Final
629
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17278 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 30991 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 305359 0
University
Name [1] 305359 0
Monash University
Country [1] 305359 0
Australia
Primary sponsor type
Individual
Name
Dr Emma Ridley
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
Country
Australia
Secondary sponsor category [1] 307015 0
None
Name [1] 307015 0
Address [1] 307015 0
Country [1] 307015 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305692 0
The Alfred Ethics Committee
Ethics committee address [1] 305692 0
Ethics committee country [1] 305692 0
Australia
Date submitted for ethics approval [1] 305692 0
Approval date [1] 305692 0
16/10/2018
Ethics approval number [1] 305692 0
531/18
Ethics committee name [2] 306696 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 306696 0
Ethics committee country [2] 306696 0
Australia
Date submitted for ethics approval [2] 306696 0
Approval date [2] 306696 0
14/08/2020
Ethics approval number [2] 306696 0
26003

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101246 0
Dr Emma Ridley
Address 101246 0
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
Country 101246 0
Australia
Phone 101246 0
+61 3 99030350
Fax 101246 0
Email 101246 0
emma.ridley@monash.edu
Contact person for public queries
Name 101247 0
Emma Ridley
Address 101247 0
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
Country 101247 0
Australia
Phone 101247 0
+61 3 99030350
Fax 101247 0
Email 101247 0
emma.ridley@monash.edu
Contact person for scientific queries
Name 101248 0
Emma Ridley
Address 101248 0
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
Country 101248 0
Australia
Phone 101248 0
+61 3 99030350
Fax 101248 0
Email 101248 0
emma.ridley@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.