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Trial registered on ANZCTR


Registration number
ACTRN12619000760178
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
22/05/2019
Date last updated
24/05/2023
Date data sharing statement initially provided
22/05/2019
Date results provided
24/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The measurement of energy needs in adult patients receiving Extracorporeal Membrane Oxygenation (ECMO) support
Scientific title
The measurement of energy expenditure in adult patients receiving veno-arterial Extracorporeal Membrane Oxygenation (ECMO)
Secondary ID [1] 297816 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 312182 0
Extracorporeal Membrane Oxygenation 312183 0
Condition category
Condition code
Emergency medicine 310733 310733 0 0
Other emergency care
Cardiovascular 311193 311193 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Veno-arterial extracorporeal membrane oxygenation (V-A ECMO) is a specialised cardiorespiratory support for patients with severe heart dysfunction. ECMO supports the circulation via a pump, and gas exchange (oxygen and carbon dioxide) occurs via an extracorporeal membrane. ECMO patients are vulnerable to both rapid weight loss as well as complications related to overfeeding. Therefore the provision of the correct amount of nutrition is an essential element of care. However, we are currently uncertain of how to accurately determine the energy they require, as gas exchange across the external membrane means current measures are inaccurate.

In this single-centre prospective observational study, the feasibility of measuring carbon dioxide production and oxygen consumption across the ECMO membrane as well as the lung will be determined in mechanically ventilated ECMO critically ill patients. Exact energy expenditure has not previously been established in V-A ECMO. This study will aim to improve the accuracy of nutrition delivery in this patient group.

The aim is to recruit a convenience sample of 30 patients and to measure energy expenditure within 72 hours of commencement of V-A ECMO and to repeat measurements on day seven following ECMO commencement.
Intervention code [1] 314060 0
Not applicable
Comparator / control treatment
Energy expenditure measurements completed within 72 hours and on day seven of ECMO commencement will be compared with energy expenditure measurements in matched non-ECMO critically ill patients (secondary outcome).

Energy expenditure data for matched non-ECMO critically ill patients will be obtained from a nutrition database research project. from The Alfred Hospital containing measurements from 2010-2018.
Control group
Historical

Outcomes
Primary outcome [1] 319581 0
Feasibility of completing energy expenditure measurements within 72 hours of ECMO commencement measured using blood gas measurements across the external membrane in addition to conventional indirect calorimetry.

Feasibility will be measured by prospectively collecting data on whether the energy expenditure measurement could or could not be completed. Real-time data during testing, indirect calorimetry data including measurement contraindications, reasons for non-completion are obtained. In addition, the bedside chart and medical records are consulted for physiologic and demographic data.
Timepoint [1] 319581 0
Within 72 hours of ECMO commencement
Secondary outcome [1] 368778 0
Feasibility of completing energy expenditure measurements on day seven following ECMO commencement.

Feasibility will be measured by prospectively collecting data on whether the energy expenditure measurement could or could not be completed. Real-time data during testing, indirect calorimetry data including measurement contraindications, reasons for non-completion are obtained. In addition, the bedside chart and medical records are consulted for physiologic and demographic data.
Timepoint [1] 368778 0
On day seven following ECMO commencement
Secondary outcome [2] 368781 0
Energy deficit compared to measured and predicted energy expenditure will be determined from hospital records.
Timepoint [2] 368781 0
o Within 72 hours of ECMO commencement
o On day seven of ECMO commencement

Eligibility
Key inclusion criteria
• Critically ill adult patients aged equal to or greater than 18 years
• Commenced on V-A ECMO for any reason
• Expected to require mechanical ventilation for at least 48 hours from initiation of ECMO
• Expected to remain in the ICU and on ECMO for at least 48 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with a poor prognosis where death is imminent in the subsequent 24 hours
• Participation in the study is not in the interest of the patient in the opinion of the treating physician

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
A convenience sample of 30 V-A ECMO patients will be recruited based on the feasibility study design and available funding.
Descriptive statistics will be used to report demographic and energy expenditure data. Differences between energy expenditure measurements in ECMO and non-ECMO patients will be analysed using multivariate analysis where applicable. Limits of agreement analysis using Bland-Altman plots and Pitman’s test of difference in variance will be performed to compare measured energy expenditure using the blood gas model and predictive equation estimates of energy expenditure.
Differences in kcal/kJ between energy expenditure measurements in patients within 72 hours of ECMO commencement (measured using blood gas measurements across the external membrane in addition to conventional indirect calorimetry) and matched critically ill patients (measured using conventional indirect calorimetry).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/06/2019
Actual
20/08/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
8/09/2021
Date of last data collection
Anticipated
28/01/2022
Actual
12/09/2021
Sample size
Target
30
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13499 0
The Alfred - Prahran
Recruitment postcode(s) [1] 26118 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 302340 0
Hospital
Name [1] 302340 0
Alfred Research Trusts Small Project Grant
Country [1] 302340 0
Australia
Primary sponsor type
Hospital
Name
The Alfred, Alfred Health
Address
55 Commercial Road, Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 302223 0
University
Name [1] 302223 0
Monash University
Address [1] 302223 0
553 St Kilda Rd, Melbourne VIC 3004
Country [1] 302223 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303015 0
Alfred Health - Alfred Hospital Human Research Ethics Committee .
Ethics committee address [1] 303015 0
Ethics committee country [1] 303015 0
Australia
Date submitted for ethics approval [1] 303015 0
28/02/2019
Approval date [1] 303015 0
20/03/2019
Ethics approval number [1] 303015 0
76/19

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

Contacts
Principal investigator
Name 92170 0
Dr Arne Diehl
Address 92170 0
The Alfred
ICU Consultant Offices
3rd Floor, East Block
55 Commercial Road
Melbourne 3004, Victoria, Australia
Country 92170 0
Australia
Phone 92170 0
+61 418342638
Fax 92170 0
Email 92170 0
a.diehl@alfred.org.au
Contact person for public queries
Name 92171 0
Arne Diehl
Address 92171 0
The Alfred
ICU Consultant Offices
3rd Floor, East Block
55 Commercial Road
Melbourne 3004, Victoria, Australia
Country 92171 0
Australia
Phone 92171 0
+61 418342638
Fax 92171 0
Email 92171 0
a.diehl@alfred.org.au
Contact person for scientific queries
Name 92172 0
Arne Diehl
Address 92172 0
The Alfred
ICU Consultant Offices
3rd Floor, East Block
55 Commercial Road
Melbourne 3004, Victoria, Australia
Country 92172 0
Australia
Phone 92172 0
+61 418342638
Fax 92172 0
Email 92172 0
a.diehl@alfred.org.au

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 of the results will not be considered due to the feasibility study design and small participant numbers in order to protect patient anonymity.


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.