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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02048046




Registration number
NCT02048046
Ethics application status
Date submitted
27/01/2014
Date registered
29/01/2014
Date last updated
29/01/2014

Titles & IDs
Public title
Nutrition Therapy in Adult Patients Requiring ECMO in Australia and New Zealand
Scientific title
Secondary ID [1] 0 0
V3 110613
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients on Extracorporeal Membrane Oxygenation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ECMO -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nutrition therapy
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Barriers and enablers
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
Those admitted to any of the participating institutions and;

* Currently receiving ECMO for any reason
* Expected to remain on ECMO for = 72 hours
* Expected that nutrition therapy will continue for at = 72 hours
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Death is imminent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Sir Charles Gardiner Hospital - Perth
Recruitment hospital [4] 0 0
The Royal Perth Hospital - Perth
Recruitment hospital [5] 0 0
Royal Prince Alfred - Sydney
Recruitment hospital [6] 0 0
St Vincents, Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients with heart and/or lung failure are some of the sickest patients in our hospital systems. In severe cases they often need long periods of specialist care in Intensive Care Units (ICU) in Australia and New Zealand. Extracorporeal Membrane Oxygenation (ECMO) is an extremely specialised and costly form of life support, only being utilised when a patient is close to death as a last resort to save their life. This form of life support has been used for many years in babies and children but is relatively new for adults. Whilst there is evidence emerging of the positive effects of ECMO in adults, there is a lot that is unknown and further research is required.

Another essential therapy that assists patients in their recovery from illness is the provision of artificial nutrition. This liquid formula is delivered into the stomach or as a nutritionally rich fluid provided into the vein. Until recently nutrition was under-emphasised in the critically ill, however, it has now become clear that targeted nutrition can positively affect a person's outcome and is vital during long periods of intensive care hospitalisation.

There is very limited data on how nutrition affects the outcomes of ECMO patients (positive or negative). We know from limited studies that these patients receive less nutrition than other patients, something that is particularly concerning given that less nutrition leads to a longer hospital stay and has been linked a with higher hospital mortality. We also think that adult patients on ECMO need more nutrition as they appear to lose more weight than patients with other illnesses in intensive care; however this has not been confirmed. It is thus essential that we understand the effects of this relatively simple but vital therapy on these very sick patients.

This study proposes to collect information on the current feeding practices in patients on ECMO and describe the factors that inhibit or allow provision of nutrition so that we can understand the issues that exist, develop strategies to improve delivery of nutrition and determine areas for further research.
Trial website
https://clinicaltrials.gov/study/NCT02048046
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02048046