Cardiac FailureNCT01551849
Echocardiographic Assessment of Function During ECMO Support
An observational study of Cardiac Failure and Extracorporeal Membrane Oxygenation Complication, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate echocardiographic markers of cardiac function to assess the ability of patients to successfully end VA-ECMO support. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Failure, Extracorporeal Membrane Oxygenation Complication
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2012to 30 Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients supported by VA-ECMO in the NICU, PICU, or CTICU.
Who may be able to join
- VA ECMO (all cannulation sites)
- Primary Cardiac Failure
- Septic Shock
Who cannot join
- VV ECMO
- Primary Respiratory Failure
- Congenital Diaphragmatic Hernia
- Persistent pulmonary hypertension of the newborn
- greater than 1 source of systemic perfusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The purpose of this study is to evaluate echocardiographic markers of cardiac function to assess the ability of patients to successfully end VA-ECMO support.
Read the detailed description
- What is the major problem being addressed by this study? Extracorporeal membrane oxygenation (ECMO) is a machine used to do the work of the heart and lungs when children's hearts or lungs are too sick to perform normally. Veno-arterial (VA) ECMO therapy for poor heart function provides support that can lead to patient recovery, transplantation if appropriate and eligible, or complications of ECMO therapy lead to stopping care. Each day a patient is on ECMO, complications can occur that require stopping support, and attempting to get off ECMO as quickly as possible is important. There is currently no consistent way of assessing heart function while patients are supported by VA-ECMO to help guide when children's hearts have improved enough to survive without the help of ECMO.
- What specific questions are you asking and how will you attempt to answer them?
The specific question we are asking is whether newer ultrasound measures of heart function can predict which patient may be well enough to be able to come off of ECMO support. We are following critically ill patients and performing multiple measurements at specific time points to look for changes in those patients whose heart function recovers and in those patients who do not recover function. The ultrasound measurements will be performed during changes in the amount of support provided by the ECMO machine.
- 3. What is the long-term biomedical significance of your work, particularly as it pertains to the cardiovascular area? What major therapeutic advance(s) do you anticipate that it will lead to? For instance, new drug(s), a surgical technique/procedure, a diagnostic tool/test, a previously undetected risk factor, etc.
Our long term goal is to develop non-invasive, quantitative measures of cardiac function for patients needing ECMO support to help guide care. Ultimately if deemed successful, these measurements could be used by all physicians who care for these patients. This study could lead to more efficient prediction of who needs to stay on ECMO and who could be removed. This could help to improve survival and decrease complications in some of the sickest children. These measurements may also help us to identify, at an early stage, those patients whose hearts are too sick to recover and will need a heart transplant evaluation.
- Medical subject headings
- Heart Failure
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 |
|---|---|---|
| VA-ECMO patients | Patients placed on VA-ECMO support for primary cardiac dysfunction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to separate from VA-ECMO support with stable hemodynamics
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study start1 Jan 2012
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FailureStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Andrew R Yates, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551849
- Sponsor's protocol ID
- IRB11-00470
- Other IDs
- 12CRP9020022
- Status last verified
- Jul 2017
- First submitted
- 9 Mar 2012
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: non-interventional trial
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Assessment of Function During ECMO Support
- ClinicalTrials.gov ID
- NCT01551849
- Acronym / sponsor ID
- IRB11-00470
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 13 Mar 2012 (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.
The purpose of this study is to evaluate echocardiographic markers of cardiac function to assess the ability of patients to successfully end VA-ECMO support.
Detailed description
- What is the major problem being addressed by this study? Extracorporeal membrane oxygenation (ECMO) is a machine used to do the work of the heart and lungs when children's hearts or lungs are too sick to perform normally. Veno-arterial (VA) ECMO therapy for poor heart function provides support that can lead to patient recovery, transplantation if appropriate and eligible, or complications of ECMO therapy lead to stopping care. Each day a patient is on ECMO, complications can occur that require stopping support, and attempting to get off ECMO as quickly as possible is important. There is currently no consistent way of assessing heart function while patients are supported by VA-ECMO to help guide when children's hearts have improved enough to survive without the help of ECMO.
- What specific questions are you asking and how will you attempt to answer them?
The specific question we are asking is whether newer ultrasound measures of heart function can predict which patient may be well enough to be able to come off of ECMO support. We are following critically ill patients and performing multiple measurements at specific time points to look for changes in those patients whose heart function recovers and in those patients who do not recover function. The ultrasound measurements will be performed during changes in the amount of support provided by the ECMO machine.
- 3. What is the long-term biomedical significance of your work, particularly as it pertains to the cardiovascular area? What major therapeutic advance(s) do you anticipate that it will lead to? For instance, new drug(s), a surgical technique/procedure, a diagnostic tool/test, a previously undetected risk factor, etc.
Our long term goal is to develop non-invasive, quantitative measures of cardiac function for patients needing ECMO support to help guide care. Ultimately if deemed successful, these measurements could be used by all physicians who care for these patients. This study could lead to more efficient prediction of who needs to stay on ECMO and who could be removed. This could help to improve survival and decrease complications in some of the sickest children. These measurements may also help us to identify, at an early stage, those patients whose hearts are too sick to recover and will need a heart transplant evaluation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VA-ECMO patients | – | –Patients placed on VA-ECMO support for primary cardiac dysfunction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients supported by VA-ECMO in the NICU, PICU, or CTICU.
Key inclusion criteria (3 listed)
- VA ECMO (all cannulation sites)
- Primary Cardiac Failure
- Septic Shock
Key exclusion criteria (5 listed)
- VV ECMO
- Primary Respiratory Failure
- Congenital Diaphragmatic Hernia
- Persistent pulmonary hypertension of the newborn
- greater than 1 source of systemic perfusion
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
Ability to separate from VA-ECMO support with stable hemodynamics
Time frame: 48 hours
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 21 Jul 2017.
- Individual participant dataSharing planned: No. non-interventional trial
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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.
Andrew R Yates, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Failure and Extracorporeal Membrane Oxygenation Complication, run by Nationwide Children's Hospital at 1 site in United States.
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 3 inclusion and 5 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Ability to separate from VA-ECMO support with stable hemodynamics (time frame: 48 hours). 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 21 Jul 2017.