Patients on Extracorporeal Membrane OxygenationNCT02048046
Nutrition Therapy in Adult Patients Requiring ECMO in Australia and New Zealand
An observational study of Patients on Extracorporeal Membrane Oxygenation, run by Australian and New Zealand Intensive Care Research Centre at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Patients on Extracorporeal Membrane Oxygenation
- How many people
- 109 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jun 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving VV or VA ECMO for longer than 72 hours
Who may be able to join
- 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
Who cannot join
- Death is imminent
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia6 sites
The Prince Charles Hospital
Brisbane
The Alfred Hospital
Melbourne
Sir Charles Gardiner Hospital
Perth
The Royal Perth Hospital
Perth
Royal Prince Alfred
Sydney
St Vincents, Sydney
Sydney
About this study
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.
Read more
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.
Read the detailed description
Aim
Our primary aims are to:
- describe the current nutrition therapy practices and
- profile the barriers and enablers to successful feeding in patients requiring VV (veno-venous) or VA (veno-arterial) ECMO whilst ECMO is insitu and for 7 days post ECMO removal.
Hypothesis We hypothesise that patients who receive VA or VV ECMO receive inadequate amounts of predicted nutrition requirements (including energy and protein) and are subject to frequent episodes of nutritional delivery interruption.
Study design A 12 month prospective, observational study in approximately 10 sites across Australia and New Zealand. Data will be collected from the commencement of ECMO until 7 days after its removal. All patients who are eligible for the study will have data collected by the primary dietitian or research coordinator at each site. Data collection has been confined to variables available in routine practice and easily available to the dietitian.
- Keywords
- ECMO, Nutrition therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ECMO | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition therapy
Describe current nutrition therapy practices in patients receiving VV or VA ECMO
Measured: 12 months
Secondary outcomes (1)
Barriers and enablers
Profile the barriers and enablers to successful feeding in patients requiring VV or VA ECMO
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJun 2012
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients on Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048046
- Sponsor's protocol ID
- V3 110613
- Status last verified
- Jan 2014
- First submitted
- 27 Jan 2014
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Therapy in Adult Patients Requiring ECMO in Australia and New Zealand
- ClinicalTrials.gov ID
- NCT02048046
- Acronym / sponsor ID
- V3 110613
- Keywords
- ECMO, Nutrition therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim
Our primary aims are to:
- describe the current nutrition therapy practices and
- profile the barriers and enablers to successful feeding in patients requiring VV (veno-venous) or VA (veno-arterial) ECMO whilst ECMO is insitu and for 7 days post ECMO removal.
Hypothesis We hypothesise that patients who receive VA or VV ECMO receive inadequate amounts of predicted nutrition requirements (including energy and protein) and are subject to frequent episodes of nutritional delivery interruption.
Study design A 12 month prospective, observational study in approximately 10 sites across Australia and New Zealand. Data will be collected from the commencement of ECMO until 7 days after its removal. All patients who are eligible for the study will have data collected by the primary dietitian or research coordinator at each site. Data collection has been confined to variables available in routine practice and easily available to the dietitian.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving VV or VA ECMO for longer than 72 hours
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Death is imminent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutrition therapy
Time frame: 12 months
Describe current nutrition therapy practices in patients receiving VV or VA ECMO
1 secondary outcome
Barriers and enablers
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients on Extracorporeal Membrane Oxygenation, run by Australian and New Zealand Intensive Care Research Centre at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.