Right Ventricular Function During Liver Transplantation as Assessed by Transesophageal Echocardiography.

March 3, 2018 updated by: GLAUBER GOUVEA, Universidade Federal do Rio de Janeiro

Intraoperative Evaluation of Right Ventricular Function During Liver Transplantation: a Quantitative Analysis Using Transesophageal Echocardiography

Cirrhotic patients undergoing liver transplantation might develop acute transient right ventricular dysfunction, ranging from mild to severe form. More than two decades ago, a number of studies with pulmonary artery catheters looked at this particular issue with controversial results. However, the pulmonary artery catheter as a monitor for right ventricular function (RVF) has several limitations, while the echocardiogram is deemed to be more accurate in this regard. Therefore, we sought to evaluate the RVF with the transesophageal echocardiogram, and particularly whether the RVF significantly varies during this procedure.

Study Overview

Status

Unknown

Detailed Description

Evaluation of right ventricular function (RVF) during orthotopic liver transplantation (OLT) has been extensively reported with modified pulmonary artery catheters that measure the right ventricular ejection fraction. However, quantitative analysis of RVF using transesophageal echocardiography (TEE) are scarce in this setting.

Methods: Nineteen cirrhotic patients who underwent OLT from April-2012 to April-2013 will be studied. Analysis of echocardiogram-derived parameters routinely used to evaluate ventricular function will be done. In particular, the RVF was quantitatively assessed by two parameters derived from TEE: tricuspid annular plane systolic excursion (TAPSE) and right ventricular fractional area change (RVFAC). Exclusion criteria: pulmonary hypertension, fulminant hepatitis, age less than 18 or greater than 65 years old and cardiopulmonary diseases. All echocardiographic and hemodynamic data set have been collected at 5 stages during the procedure, according to Institutional Protocol: baseline, hepatectomy, anhepatic phase, post-reperfusion, and closure.

Statistical Analysis: One-way ANOVA for repeated measurements will be used if the data have normal distribution, otherwise Friedman test will be used. P<0.05 is to be considered significant.

Study Type

Observational

Enrollment (Actual)

19

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

      • Rio De Janeiro, Brazil, 21941590
        • Federal University of Rio de Janeiro

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult cirrhotic patients who underwent a orthotopic liver transplantation

Description

Inclusion Criteria:

  • Adult patients who underwent orthotopic liver transplantation from april 2012 to april 2013.

Exclusion Criteria:

  • Pulmonary hypertension (any type)
  • Cardiopulmonary disease (eg: chronic obstructive pulmonary disease (COPD), valvular heart disease, ischemic heart disease)
  • Fulminant hepatitis.

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
Development of new right ventricular dysfunction during liver transplantation
Time Frame: Through study completion, after 1 year of data retrieval and analysis.
Signs of right ventricular dysfunction as assessed by transesophageal echocardiography
Through study completion, after 1 year of data retrieval and analysis.

Collaborators and Investigators

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

Investigators

  • Study Chair: Nubia V Figueiredo, MSc, PhD, Universidade Federal do Rio de Janeiro

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)

February 27, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

March 3, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 3, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 79763817.9.0000.5257

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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