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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]

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

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]

Nutrition therapy

Timepoint [1]

12 months

Secondary outcome [1]

Barriers and enablers

Timepoint [1]

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?

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]

The Prince Charles Hospital - Brisbane

Recruitment hospital [2]

The Alfred Hospital - Melbourne

Recruitment hospital [3]

Sir Charles Gardiner Hospital - Perth

Recruitment hospital [4]

The Royal Perth Hospital - Perth

Recruitment hospital [5]

Royal Prince Alfred - Sydney

Recruitment hospital [6]

St Vincents, Sydney - Sydney

Recruitment postcode(s) [1]

- Brisbane

Recruitment postcode(s) [2]

- Melbourne

Recruitment postcode(s) [3]

- Perth

Recruitment postcode(s) [4]

- Sydney

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02048046

Trial Review

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