Echocardiographic Assessment of Function During ECMO Support



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/2/2016
Start Date:January 2012
End Date:December 2017
Contact:Andrew R. Yates, M.D.
Email:andrew.yates@nationwidechildrens.org
Phone:614-722-0596

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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.

1. 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.

2. 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.

Inclusion Criteria:

- VA ECMO (all cannulation sites)

- Primary Cardiac Failure

- Septic Shock

Exclusion Criteria:

- VV ECMO

- Primary Respiratory Failure

- Congenital Diaphragmatic Hernia

- Persistent pulmonary hypertension of the newborn

- greater than 1 source of systemic perfusion
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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