Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000304639
Ethics application status
Approved
Date submitted
2/03/2023
Date registered
17/03/2023
Date last updated
17/03/2024
Date data sharing statement initially provided
17/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutrition Practices Across Hospitalisation in Adult Patients requiring Extracorporeal Membrane Oxygenation in Australia.
Scientific title
Nutrition Practices Across Hospitalisation in Adult Patients requiring Extracorporeal Membrane Oxygenation in Australia - A National, Registry Linked, Prospective Cohort Study (ECMO-Nutrition)
Secondary ID [1] 309063 0
Nil
Universal Trial Number (UTN)
Trial acronym
ECMO-Nutrition
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critical illness
 329123 0
Condition category
Condition code
Diet and Nutrition 326096 326096 0 0
Other diet and nutrition disorders
Public Health 326097 326097 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
Extracorporeal membrane oxygenation (ECMO) is commonly used as a salvage therapy for patients with refractory heart or lung failure when other medical management has failed. Despite nutrition therapy being an accepted standard of care within this population, there remains scant evidence to inform practice. Existing observational studies indicate that patients who receive ECMO consistently receive less nutrition than prescribed whilst in the Intensive Care Unit (ICU); however, the significance of this in relation to clinical outcomes remains to be explored. Moreover, patients typically experience significant losses of muscle mass, strength, and debilitating fatigue resulting in persistent disability after hospital discharge. Given the prolonged length of ICU and hospital stay for patients receiving ECMO, it is plausible nutrition provision across hospitalisation may represent a modifiable factor that has the potential to alter outcomes and influence recovery. However, no studies have explored nutrition provision following ICU discharge in patients who received ECMO. Thus, the aim of this prospective registry linked cohort study is to describe current nutrition delivery practices and provision in patients receiving ECMO in Australia across hospitalisation between June 2022-September 2023 and explore the association between nutrition provision with clinical and long-term outcomes. Additionally, this study will explore changes in nutrition provision over the last decade in patients who have received ECMO in Australia via comparison with a previous data set. To streamline processes the study is linked with a pre-existing national registry (The Australian and New Zealand extracorporeal membrane oxygenation registry [EXCEL]) to obtain data on baseline and long term clinical and functional outcomes. Data on nutrition delivery processes and provision will be collected at each site (including mode, barriers and enablers) via review of patient medical records until day 60, acute hospital transfer or death (whichever occurs earliest). Data at 6 months will be extracted from the EXCEL registry. The EXCEL registry follow up data is collected by trained assessors using telephone interviews including responses to the following instruments:
Quality of life assessed using the EQ-5D-5L questionnaire
Physical activity assessed using the Instrumental Activities of Daily Living (IADL) questionnaire and Barthel Activities of Daily Living (ADL) index
Intervention code [1] 325505 0
Diagnosis / Prognosis
Comparator / control treatment
Comparison will be made with a previous data set collected as part of a prospective multicentre observational study completed in 2012 by CI Dr Ridley. This previous study enrolled 107 patients across eight ICUs in Australia and New Zealand and collected data on nutrition provision from ECMO commencement until seven days post decannulation. Data was collected from review of the individual patient's medical records and ICU charts. Reference: Ridley EJ, et al. Nutrition therapy in adult patients receiving extracorporeal membrane oxygenation: a prospective, multicentre, observational study. Crit Care Resusc. 2015;17(3):183-9.
Control group
Historical

Outcomes
Primary outcome [1] 333961 0
Energy provision across hospitalisation in patients who receive ECMO in ANZ . Energy provision from both modes of ECMO Veno-venous (VV) or Veno -Arterial (VA) with be assessed as a composite outcome. Total delivered energy will be calculated from the sum all sources (EN/PN/IV dextrose/propofol/IV protein modulars), minus any discarded gastric residual volumes for EN with this data being extracted from review of patient's medical records.
Timepoint [1] 333961 0
Assessed at day 1 (the day of ECMO cannulation), day 3, 7 and then 7-day intervals thereafter until day 60, acute hospital discharge/transfer or death, whichever occurs earliest.
Secondary outcome [1] 418864 0
Protein provision across hospitalisation. Total protein received will be calculated from the sum of all sources (EN/PN/IV protein modulars), minus any discarded gastric residual volumes from EN using information extracted from the patient's medical record.
Timepoint [1] 418864 0
Assessed at day 1 (the day of ECMO cannulation), day 3, 7 and then 7-day intervals thereafter until day 60, acute hospital discharge/transfer or death, whichever occurs earliest.
Secondary outcome [2] 419595 0
Energy and protein provision within ICU . Total delivered energy and protein will be calculated from the sum all sources (EN/PN/IV dextrose/propofol/IV protein modulars), minus any discarded gastric residual volumes for EN with this data being extracted from review of patient's medical records.
Timepoint [2] 419595 0
Assessed at day 1 (the day of ECMO cannulation), day 3, 7 and then 7-day intervals thereafter until ICU discharge.
Secondary outcome [3] 419596 0
Frequency of interruptions to nutrition delivery across hospitalisation. The total number of feeding interruptions ( including fasting and elevated gastric residual volumes) will be extracted from review of patient medical records.
Timepoint [3] 419596 0
Assessed at day 1 (the day of ECMO cannulation), day 3, 7 and then 7-day intervals thereafter until day 60, acute hospital discharge/transfer or death, whichever occurs earliest.
Secondary outcome [4] 419597 0
Reasons for interruptions to nutrition delivery across hospitalisation ( tertiary outcome). Data on the reasons for interruptions to feeding including fasting, elevated gastric residual volumes and enteral tube removal will be extracted from review of patient medical records.
Timepoint [4] 419597 0
Assessed at day 1 (the day of ECMO cannulation), day 3, 7 and then 7-day intervals thereafter until day 60, acute hospital discharge/transfer or death, whichever occurs earliest.
Secondary outcome [5] 419598 0
Prevalence of nutrition impact symptoms across hospitalisation ( tertiary outcome). Data on nutrition impacts symptoms will be extracted from review of patient medical records.
Timepoint [5] 419598 0
Assessed at day 1 (the day of ECMO cannulation), day 3, 7 and then 7-day intervals thereafter until day 60, acute hospital discharge/transfer or death, whichever occurs earliest.
Secondary outcome [6] 419599 0
Number of dietetic reviews during and following ICU discharge ( tertiary outcome). The number of dietetic review will be calculated from review of the patient medical record.
Timepoint [6] 419599 0
Data on the frequency of dietetic reviews within ICU will be calculated as the sum of all reviews from day 1 of ECMO to ICU discharge and the total number of reviews following ICU discharge will be calculated using the sum of all dietetic reviews completed from ICU discharge until day 60, acute hospital transfer or discharge or death, whichever occurs earliest.
Secondary outcome [7] 419600 0
Weight change across hospitalisation ( tertiary outcome). Measured weights ( the first and last measured weight recorded during the study period) will be extracted from patient medical records.
Timepoint [7] 419600 0
Data on measured weights will be collected at day 60, hospital transfer/ discharge or death, whichever occurs earliest.
Secondary outcome [8] 419601 0
Duration of ECMO ( tertiary outcome). Data on the duration of ECMO will be extracted via linkage at the conclusion of this study with the EXCEL registry. The EXCEL registry collects data on the duration of ECMO via review of patient's medical record
Timepoint [8] 419601 0
Data linkage with EXCEL will be completed once all study data collection for this project has been completed.
Secondary outcome [9] 419602 0
Duration of mechanical ventilation ( tertiary outcome). Data on the duration of mechanical ventilation will be extracted via linkage with the EXCEL registry. The EXCEL registry collects data via review of patient's medical records.
Timepoint [9] 419602 0
Data linkage with EXCEL will be completed once all study data collection for this project has been completed.
Secondary outcome [10] 419603 0
ICU length of stay (tertiary outcome). Data on ICU length of stay will be collected via linkage with the EXCEL registry. The EXCEL registry collects this data via review of patient medical records.
Timepoint [10] 419603 0
Linkage with the EXCEL registry will be performed at completion of study data collection for this project,
Secondary outcome [11] 419604 0
Hospital length of stay ( tertiary outcome) . Data on Hospital length of stay will be collected via linkage with the EXCEL registry. The EXCEL registry collects this data via review of patient medical records.
Timepoint [11] 419604 0
Linkage with the EXCEL registry will be performed at completion of study data collection for this project,
Secondary outcome [12] 419605 0
Survival ( tertiary outcome). Data on survival will be extracted via linkage with the EXCEL registry. The registry collects information on survival via review of patient medical records
Timepoint [12] 419605 0
Linkage with the EXCEL registry will be performed at completion of study data collection for this project,
Secondary outcome [13] 419606 0
Health related quality of life at 6 months ( tertiary outcome). Data on Health Related quality of life will be extracted from the EXCEL registry . This data is collected using the EQ-5D-5L questionnaire administered via trained assessors using telephone interviews of patients or their surrogates at 6 months.
Timepoint [13] 419606 0
6-months
Secondary outcome [14] 419607 0
Activities of daily living at 6 months ( tertiary outcome) This data is collected using the Instrumental Activities of Daily Living (IADL) questionnaire and Barthel Activities of Daily Living (ADL) index administered via trained assessors using telephone interviews of patients or their surrogates at 6 months.
Timepoint [14] 419607 0
6-months

Eligibility
Key inclusion criteria
• Receiving ECMO in an adult hospital
• Enrolled in the EXCEL registry
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Receiving ECMO for the purpose of ECPR (Extracorporeal cardiopulmonary resuscitation)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Results will be presented as counts (%), means (standard deviations) or medians (interquartile range) according to data type and distribution. Statistical significance will be set at a p-value of 0.05. Patients who are deceased within 72 hours of enrolment will be excluded from primary outcome analysis. The data for this study will be compared with data from the previous prospective study completed by CI Ridley (https://pubmed.ncbi.nlm.nih.gov/26282256/). Comparisons between cohorts (2012 vs 2022) will be made using chi-square tests for equal proportions (or Fisher’s exact test where numbers are small) for categorical variables, independent-samples t test for normally distributed data and the Mann-Whitney U test for non-normally distributed continuous data. Nutritional adequacy throughout admission in patients will be compared using paired samples t test or Wilcoxon signed-rank test as appropriate. Comparison of nutrition data across time will be performed using linear mixed modelling fitting main effects for cohort (2012 vs 2022), ICU Day (1,3,7) and an interaction between the two factors. Associations between nutrition delivery and long-term outcomes will be explored using mixed linear and logistic modelling for normally distributed outcomes and binomial outcomes respectively, with robust errors to account for within site clustering. Multivariable sensitivity analysis will be performed adjusting for known covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/06/2022
Date of last participant enrolment
Anticipated
30/09/2023
Actual
9/07/2023
Date of last data collection
Anticipated
30/11/2023
Actual
4/08/2023
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 24104 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 24105 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 24106 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 24107 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 24108 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [6] 24109 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 24110 0
The Alfred - Melbourne
Recruitment hospital [8] 24111 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [9] 24112 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 26284 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 39612 0
4215 - Southport
Recruitment postcode(s) [2] 39613 0
2305 - New Lambton
Recruitment postcode(s) [3] 39614 0
2170 - Liverpool
Recruitment postcode(s) [4] 39615 0
2050 - Camperdown
Recruitment postcode(s) [5] 39616 0
2010 - Darlinghurst
Recruitment postcode(s) [6] 39617 0
5000 - Adelaide
Recruitment postcode(s) [7] 39618 0
3004 - Melbourne
Recruitment postcode(s) [8] 39619 0
3050 - Parkville
Recruitment postcode(s) [9] 39620 0
6150 - Murdoch
Recruitment postcode(s) [10] 42255 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 313268 0
Charities/Societies/Foundations
Name [1] 313268 0
The Australasian Society of Parenteral and Enteral Nutrition
Country [1] 313268 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)
Address
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)
School of Public Health and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC 3004
Australia
Country
Australia
Secondary sponsor category [1] 315004 0
None
Name [1] 315004 0
Address [1] 315004 0
Country [1] 315004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312498 0
Alfred Hospital Research Ethics Committee
Ethics committee address [1] 312498 0
Ethics committee country [1] 312498 0
Australia
Date submitted for ethics approval [1] 312498 0
16/12/2021
Approval date [1] 312498 0
18/01/2022
Ethics approval number [1] 312498 0
LR 693/21
Ethics committee name [2] 312499 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 312499 0
Ethics committee country [2] 312499 0
Australia
Date submitted for ethics approval [2] 312499 0
19/05/2022
Approval date [2] 312499 0
19/05/2022
Ethics approval number [2] 312499 0
32578

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

Contacts
Principal investigator
Name 124878 0
Dr Emma Ridley
Address 124878 0
Australian and New Zealand Intensive Care Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC, 3004
Australia
Country 124878 0
Australia
Phone 124878 0
+61 3 9903 0350
Fax 124878 0
Email 124878 0
[email protected]
Contact person for public queries
Name 124879 0
Emma Ridley
Address 124879 0
Australian and New Zealand Intensive Care Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC, 3004
Australia
Country 124879 0
Australia
Phone 124879 0
+61 3 9903 0350
Fax 124879 0
Email 124879 0
[email protected]
Contact person for scientific queries
Name 124880 0
Emma Ridley
Address 124880 0
Australian and New Zealand Intensive Care Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC, 3004
Australia
Country 124880 0
Australia
Phone 124880 0
+61 3 9903 0350
Fax 124880 0
Email 124880 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
This project is an observational non interventional study of routine clinical practice in a complex cohort who at the time of eligibility will be critically unwell and unable to provide informed consent. A waiver of consent has been granted and no results will be directly communicated with participants or their families. To ensure patient privacy is maintained all results will be presented in aggregate form.


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.