Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation

April 8, 2024 updated by: Stephen Aniskevich, III, Mayo Clinic

Evaluation of Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation

Researchers are trying to improve the understanding of systolic function of the heart at the time of liver reperfusion in patients undergoing orthotopic liver transplantation.

Study Overview

Status

Terminated

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Sequential liver transplant candidates (adults) will be approached for consent to participate in the study at the time of liver transplantation by a member of the liver anesthesia team.

Description

Inclusion Criteria:

  • Age greater than 18 years
  • Undergoing primary orthotopic liver transplantation

Exclusion Criteria:

  • Redo orthotopic transplantation
  • Acute or fulminant liver failure
  • Patient with pre-existing atrial fibrillation or hypertrophic cardiomyopathy
  • Patients with an abnormal preoperative stress test (EF <55%, areas of prior infarct, ongoing ischemia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of change in cardiac strain
Time Frame: Up to 1 hour after graft reperfusion
Evaluate the degree of change to cardiac strain using speckle tracking echocardiography
Up to 1 hour after graft reperfusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of right and left ventricular strain
Time Frame: Up to 5 hours from the time of surgery start
Describe the pattern of right and left ventricular strain throughout the course of orthotopic liver transplantion.
Up to 5 hours from the time of surgery start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Stephen Aniskevich, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Actual)

April 8, 2024

Study Completion (Actual)

April 8, 2024

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 20-001209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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