Right Ventricular Function During Liver Transplantation a... | NCT03459924

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

NCT03459924

Sponsor

Universidade Federal do Rio de Janeiro

Status

Unknown status

Last Update Posted

Mar 9, 2018Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Liver Transplant; Complications

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2018Actual

Primary Completion Date

Jan 1, 2019Estimated

Completion Date

Jan 1, 2019Estimated

First Submitted Date

Feb 27, 2018

First Submission Date that Met QC Criteria

Mar 3, 2018

First Posted Date

Mar 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2018

Last Update Posted Date

Mar 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

GLAUBER GOUVEA, Principal Investigator, Universidade Federal do Rio de JaneiroPrincipal Investigator

Lead Sponsor

Universidade Federal do Rio de JaneiroOTHER

Collaborators

Name	Class
University of California, San Francisco	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Adult cirrhotic patients who underwent a orthotopic liver transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nubia V Figueiredo, MSc, PhD	Universidade Federal do Rio de Janeiro	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Rio de Janeiro		Rio de Janeiro		21941590	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2660629	Background	Ellis JE, Lichtor JL, Feinstein SB, Chung MR, Polk SL, Broelsch C, Emond J, Thistlethwaite JR, Roizen MF. Right heart dysfunction, pulmonary embolism, and paradoxical embolization during liver transplantation. A transesophageal two-dimensional echocardiographic study. Anesth Analg. 1989 Jun;68(6):777-82.
8452268	Background

Type	Date	Date Unknown
Release	Nov 19, 2022
Reset	Sep 27, 2023
Release	Sep 28, 2023
Reset	Mar 29, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 19, 2022			Sep 27, 2023
Sep 28, 2023