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Echocardiographic Assessment of Function During ECMO Support

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01551849
First Posted: March 13, 2012
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Nationwide Children's Hospital
  Purpose
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.

Condition
Cardiac Failure Extracorporeal Membrane Oxygenation Complication

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Echocardiographic Assessment of Function During ECMO Support

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Ability to separate from VA-ECMO support with stable hemodynamics [ Time Frame: 48 hours ]

Enrollment: 5
Actual Study Start Date: January 1, 2012
Study Completion Date: December 30, 2016
Primary Completion Date: December 30, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
VA-ECMO patients
Patients placed on VA-ECMO support for primary cardiac dysfunction.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients supported by VA-ECMO in the NICU, PICU, or CTICU.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551849


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
American Heart Association
Investigators
Principal Investigator: Andrew R Yates, MD Nationwide Children's Hospital
  More Information

Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01551849     History of Changes
Other Study ID Numbers: IRB11-00470
12CRP9020022 ( Other Grant/Funding Number: AHA 12CRP9020022 )
First Submitted: March 9, 2012
First Posted: March 13, 2012
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: non-interventional trial

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases