- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03459924
Right Ventricular Function During Liver Transplantation as Assessed by Transesophageal Echocardiography.
Intraoperative Evaluation of Right Ventricular Function During Liver Transplantation: a Quantitative Analysis Using Transesophageal Echocardiography
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Rio De Janeiro, Brazil, 21941590
- Federal University of Rio de Janeiro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Study Chair: Nubia V Figueiredo, MSc, PhD, Universidade Federal do Rio de Janeiro
Publications and helpful links
General Publications
- 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.
- De Wolf AM, Begliomini B, Gasior TA, Kang Y, Pinsky MR. Right ventricular function during orthotopic liver transplantation. Anesth Analg. 1993 Mar;76(3):562-8. doi: 10.1213/00000539-199303000-00020.
- Gouvea G, Diaz R, Auler L, Martinho JM. Evaluation of the right ventricular ejection fraction during orthotopic liver transplantation under propofol anaesthesia. Br J Anaesth. 2008 Aug;101(2):161-5. doi: 10.1093/bja/aen145. Epub 2008 Jun 4.
- Gouvea G, Diaz R, Auler L, Toledo R, Martinho JM. Right ventricular ejection fraction during orthotopic liver transplantation: does anesthetic technique make a difference? J Crit Care. 2010 Dec;25(4):657.e1-6. doi: 10.1016/j.jcrc.2010.02.005. Epub 2010 Apr 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Liver Transplant; Complications
-
PilloxaTerminatedLiver Transplant; Complications | Kidney Transplant; ComplicationsSweden
-
Zhejiang UniversityNot yet recruitingLiver Transplant; Complications
-
Institute of Liver and Biliary Sciences, IndiaRecruitingLiver Transplant; ComplicationsIndia
-
Société Française d'Anesthésie et de RéanimationLaboratoire français de Fractionnement et de BiotechnologiesNot yet recruitingLiver Transplant; ComplicationsFrance
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingLiver Transplant; ComplicationsItaly
-
Hospital Universitari Vall d'Hebron Research InstituteCompletedLiver Transplant; ComplicationsSpain
-
Seoul St. Mary's HospitalEnrolling by invitationLiver Transplant; ComplicationsKorea, Republic of
-
Boston Scientific CorporationCompletedLiver Transplant; ComplicationsSpain, United States, Netherlands, Brazil
-
Seoul National University HospitalCompletedLiver Transplant; ComplicationsKorea, Republic of
-
Ain Shams UniversityCompletedLiver Transplant; ComplicationsEgypt