Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000906651
Ethics application status
Approved
Date submitted
9/08/2022
Date registered
23/08/2023
Date last updated
23/08/2023
Date data sharing statement initially provided
23/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Energy needs in adult critically ill patients with infection.
Scientific title
Measured vs estimated energy needs in critically ill patients with a suspected infection: a feasibility study.
Secondary ID [1] 310285 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 325665 0
Condition category
Condition code
Diet and Nutrition 323014 323014 0 0
Other diet and nutrition disorders
Public Health 323015 323015 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 is the gold standard in the determination of energy needs of critically ill patients. Current practice is to use less accurate estimations of energy requirements using predictive methods which are quicker and lower cost. There is minimal data on energy needs during the course of ICU admission in critically ill patients with infection and the feasibility of indirect calorimetry in a busy Intensive Care Unit (ICU).
Indirect calorimetry measurement results, along with clinical judgement will be used to adjust feeding prescription for the participant if required, as part of clinical practice.

Study design: Prospective single-centre quantitative observational study conducted at Sir Charles Gairdner Hospital (SCGH) ICU, Perth, Australia commencing August 2021.

Participant recruitment: The SCGH ICU Dietitian will screen ICU admissions daily on weekdays for eligibility criteria via a screening log.

Population: Inclusion criteria includes admission to the ICU with a suspected infection requiring vasopressors, greater than or equal to 18 years of age and mechanically ventilated, with an expected ICU length of stay (LOS) of greater than 24 hours.

Data collection: Recruited subjects will have an indirect calorimetry measure conducted by a Senior ICU Dietitian trained in indirect calorimetry each week day until extubation or after four weeks, whichever is reached first. The testing time for each indirect calorimetry measure will be a maximum of 60 minutes, and tests included with a minimum of five continuous minutes of steady state. Demographic, nutrition, clinical, indirect calorimetry, feasibility and outcome variables of interest will be collected daily for the duration of the study period (that is, until extubation or after four weeks, whichever is reached first).

Indirect calorimetry results obtained will be considered based on clinical judgement for energy provision as part of the feeding regime.
Intervention code [1] 323147 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330781 0
Daily energy expenditure is being measured using indirect calorimetry (QUARK RMR).
Timepoint [1] 330781 0
Daily throughout ICU admission until extubation or after four weeks, whichever comes first.
Primary outcome [2] 335641 0
Daily energy expenditure is being estimated using predictive methods (weight based, penn state and schofield equations)
Timepoint [2] 335641 0
Daily throughout ICU admission until extubation or after four weeks, whichever comes first.
Primary outcome [3] 335642 0
Feasibility of indirect calorimetry (QUARK RMR) is being assessed by measuring time involved (using a stopwatch timer), and recording the number of tests not completed, number of tests interrupted, and reasons for test interruptions.
Timepoint [3] 335642 0
Daily for each indirect calorimetry measurement until extubation or after four weeks, whichever comes first.
Secondary outcome [1] 407539 0
Correlations between measured energy expenditure (using QUARK RMR) and infection markers is being described using C-reactive protein (CRP) levels from serum blood sample.
Timepoint [1] 407539 0
Daily for each indirect calorimetry measurement until extubation or after four weeks, whichever comes first.
Secondary outcome [2] 425695 0
Correlations between measured energy expenditure (using QUARK RMR) and infection severity predictors is being described using lactate levels from blood sample (arterial blood gas (ABG) or venous blood gas (VBG)).
Timepoint [2] 425695 0
Daily for each indirect calorimetry measurement until extubation or after four weeks, whichever comes first.
Secondary outcome [3] 425696 0
Correlations between measured energy expenditure (using QUARK RMR) and infection severity predictors is being described using vasopressor levels recorded from the ICU Flow Chart.
Timepoint [3] 425696 0
Daily for each indirect calorimetry measurement until extubation or after four weeks, whichever comes first.
Secondary outcome [4] 425697 0
Correlations between measured energy expenditure (using QUARK RMR) and infection severity predictors is being described using sequential organ failure assessment (SOFA) from ICU Flow Chart and blood samples.
Timepoint [4] 425697 0
Daily for each indirect calorimetry measurement until extubation or after four weeks, whichever comes first.

Eligibility
Key inclusion criteria
Critically ill adult mechanically ventilated patients admitted to the SCGH ICU, Perth, Australia from August 2021.
Inclusion criteria:
- Intubated and ventilated with an expected ICU LOS greater than 24 hours
- Have a suspected infection requiring vasopressors as documented by the medical team
- Greater than or equal to 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
- Continuous renal replacement therapy (CRRT)
- Extracorporeal membrane oxygenation (ECMO)
- Leaking endotracheal or tracheostomy tubes
- Presence of chest drains or bronchopleural fistula
- Fraction of inspired oxygen (FiO2) greater than 50%
- Positive end-expiratory pressure (PEEP) greater than 10

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All patient demographic and baseline clinical data will be summarised using means and standard deviations or medians and interquartile ranges for continuous data and frequency distributions (n, %) for categorical data. Longitudinal percent difference of energy expenditure compared to predictive methods (ie. value from predictive equations, calorie/kg) will be examined using generalised linear mixed models (GLMM). Change in percent difference between timepoints will be assessed. Bland-Altman plots will be used to visually assess the different energy expenditure measurement methods (indirect calorimetry, predictive equations, calorie/kg). GLMM will also be used to examine the association between infection markers and infection severity predictors and energy expenditure over time. Energy expenditure models may be adjusted for patient covariates that may have a destabilising effect on energy expenditure. Time taken to complete measurements will be modelled over time using mixed effects negative binomial models. Model results will be summarised using estimated mean percent difference and 95% confidence intervals (CI). Stata version 18.0 (StataCorp, College Station, TX) will be used for data analysis.
An expected sample of 40 patients is a convenience sample based on the expected number of patients in ICU over 12-18 months that meet the criteria and able to have measurements carried out by the Dietitian as part of their usual clinical caseload.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/08/2021
Date of last participant enrolment
Anticipated
Actual
9/03/2023
Date of last data collection
Anticipated
Actual
13/03/2023
Sample size
Target
40
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21985 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 37086 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 311032 0
Hospital
Name [1] 311032 0
North Metropolitan Health Service Building Allied Health Research Capacity
Country [1] 311032 0
Australia
Primary sponsor type
Individual
Name
Bianca Mammana
Address
Dietetics Department
Sir Charles Gairdner Hospital
Level 3, A Block, Hospital Avenue
Nedlands, Western Australia, 6009
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 312356 0
Individual
Name [1] 312356 0
Emma Osnain
Address [1] 312356 0
Dietetics Department
Sir Charles Gairdner Hospital
Level 3, A Block, Hospital Avenue
Nedlands, Western Australia, 6009
AUSTRALIA
Country [1] 312356 0
Australia
Secondary sponsor category [2] 313506 0
Individual
Name [2] 313506 0
Stefanie Simnadis
Address [2] 313506 0
Dietetics Department
Sir Charles Gairdner Hospital
Level 3, A Block, Hospital Avenue
Nedlands, Western Australia, 6009
AUSTRALIA
Country [2] 313506 0
Australia
Other collaborator category [1] 282403 0
University
Name [1] 282403 0
Janica Jamieson
Address [1] 282403 0
Edith Cowan University
270 Joondalup Drive
Joondalup, Western Australia, 6027
AUSTRALIA
Country [1] 282403 0
Australia
Other collaborator category [2] 282404 0
University
Name [2] 282404 0
Catherine Properzi
Address [2] 282404 0
Edith Cowan University
270 Joondalup Drive
Joondalup, Western Australia, 6027
AUSTRALIA
Country [2] 282404 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310580 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee and Research Governance Office
Ethics committee address [1] 310580 0
Ethics committee country [1] 310580 0
Australia
Date submitted for ethics approval [1] 310580 0
Approval date [1] 310580 0
07/06/2018
Ethics approval number [1] 310580 0

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

Contacts
Principal investigator
Name 118154 0
Mrs Bianca Mammana
Address 118154 0
Dietetics Department
Sir Charles Gairdner Hospital
Level 3, A Block, Hospital Avenue
Nedlands, Western Australia, 6009
AUSTRALIA
Country 118154 0
Australia
Phone 118154 0
+61 8 6457 2850
Fax 118154 0
Email 118154 0
[email protected]
Contact person for public queries
Name 118155 0
Bianca Mammana
Address 118155 0
Dietetics Department
Sir Charles Gairdner Hospital
Level 3, A Block, Hospital Avenue
Nedlands, Western Australia, 6009
AUSTRALIA
Country 118155 0
Australia
Phone 118155 0
+61 8 6457 2850
Fax 118155 0
Email 118155 0
[email protected]
Contact person for scientific queries
Name 118156 0
Bianca Mammana
Address 118156 0
Dietetics Department
Sir Charles Gairdner Hospital
Level 3, A Block, Hospital Avenue
Nedlands, Western Australia, 6009
AUSTRALIA
Country 118156 0
Australia
Phone 118156 0
+61 8 6457 2850
Fax 118156 0
Email 118156 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing not included as an option as part of ethics application submission.


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.