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

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ClinicalTrials.gov Identifier: NCT03459924
Recruitment Status : Active, not recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
GLAUBER GOUVEA, Universidade Federal do Rio de Janeiro

Brief Summary:
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.

Condition or disease
Liver Transplant; Complications

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.


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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intraoperative Evaluation of Right Ventricular Function During Liver Transplantation: a Quantitative Analysis Using Transesophageal Echocardiography
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

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Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult cirrhotic patients who underwent a orthotopic liver transplantation
Criteria

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.

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): NCT03459924


Locations
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Brazil
Federal University of Rio de Janeiro
Rio De Janeiro, Brazil, 21941590
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
University of California, San Francisco
Investigators
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Study Chair: Nubia V Figueiredo, MSc, PhD Universidade Federal do Rio de Janeiro

Publications:
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Responsible Party: GLAUBER GOUVEA, Principal Investigator, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT03459924     History of Changes
Other Study ID Numbers: 79763817.9.0000.5257
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GLAUBER GOUVEA, Universidade Federal do Rio de Janeiro:
Right ventricular function
Liver transplantation
Transesophageal echocardiography