Echocardiographic Assessment of Function During ECMO Support

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

Echocardiographic Assessment of Function During ECMO Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551849
• Other study ID #: IRB11-00470
• Secondary ID: 12CRP9020022
• Status: Completed
• Phase: N/A
• First received: March 9, 2012
• Last updated: July 19, 2017
• Start date: January 1, 2012
• Est. completion date: December 30, 2016

Study information

• Verified date: July 2017
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Failure
• Extracorporeal Membrane Oxygenation Complication
• Heart Failure

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to separate from VA-ECMO support with stable hemodynamics		48 hours