Clinical trial NCT01551849: Echocardiographic Assessment of Function During ECMO Support
Official title: Echocardiographic Assessment of Function During ECMO Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Failure
Extracorporeal Membrane Oxygenation Complication
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2012-03-13
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients supported by VA-ECMO in the NICU, PICU, or CTICU.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ability to separate from VA-ECMO support with stable hemodynamics
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Andrew R Yates, MD
role: PRINCIPAL_INVESTIGATOR
References: