NCT04316468

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

4.1 years

First QC Date

March 19, 2020

Last Update Submit

April 8, 2024

Conditions

Liver Transplant DisorderReperfusion Injury

Outcome Measures

Primary Outcomes (1)

  • Degree of change in cardiac strain

    Evaluate the degree of change to cardiac strain using speckle tracking echocardiography

    Up to 1 hour after graft reperfusion

Secondary Outcomes (1)

  • Pattern of right and left ventricular strain

    Up to 5 hours from the time of surgery start

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen Aniskevich, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 20, 2020

Study Start

March 10, 2020

Primary Completion

April 8, 2024

Study Completion

April 8, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)