- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04316468
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
Conditions
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.
Helpful Links
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Reperfusion Injury
-
University of ChileFondo Nacional de Desarrollo Científico y Tecnológico, ChileCompletedReperfusion Injury | Acute Myocardial Infarction | Ischemia-reperfusion Injury | Reperfusion Injury, Myocardial | Reperfusion ArrhythmiasChile
-
University of AarhusCompletedReperfusion Injuries, Myocardial
-
University of AarhusErasmus Medical Center; Fonden til Lægevidenskabens FremmeCompletedIschemia Reperfusion Injury | Ischaemia Reperfusion InjuryDenmark
-
Indonesia UniversityEnrolling by invitationReperfusion Injury, MyocardialIndonesia
-
Chinese PLA General HospitalUnknown
-
West Kazakhstan Medical UniversityRecruitingKidney Transplantation | Ischemic Reperfusion Injury | ReperfusionKazakhstan
-
Cukurova UniversityCompleted
-
Chinese PLA General HospitalUnknownReperfusion Injury, Myocardial
-
Shahid Beheshti University of Medical SciencesPooyesh DarouCompletedMyocardial Ischemic Reperfusion InjuryIran, Islamic Republic of
-
Samsung Medical CenterCompletedIschemia/Reperfusion Injury of Liver Graft | Ischemia/Reperfusion Injury of Kidney | Remote Ischemic PostconditioningKorea, Republic of