Patients on Extracorporeal Membrane Oxygenation Clinical Trial
| NCT number | NCT02048046 |
| Other study ID # | V3 110613 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | January 27, 2014 |
| Last updated | January 27, 2014 |
| Start date | June 2012 |
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.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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 Exclusion Criteria: • Death is imminent |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Prince Charles Hospital | Brisbane | |
| Australia | The Alfred Hospital | Melbourne | |
| Australia | Sir Charles Gardiner Hospital | Perth | |
| Australia | The Royal Perth Hospital | Perth | |
| Australia | Royal Prince Alfred | Sydney | |
| Australia | St Vincents, Sydney | Sydney | |
| New Zealand | Auckland City Hospital (CVICU) | Auckland |
| Lead Sponsor | Collaborator |
|---|---|
| Australian and New Zealand Intensive Care Research Centre |
Australia, New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Nutrition therapy | Describe current nutrition therapy practices in patients receiving VV or VA ECMO | 12 months | No |
| Secondary | Barriers and enablers | Profile the barriers and enablers to successful feeding in patients requiring VV or VA ECMO | 12 months | No |