Clinical trial NCT03459924: Right Ventricular Function During Liver Transplantation as Assessed by Transesophageal Echocardiography.
Official title: Intraoperative Evaluation of Right Ventricular Function During Liver Transplantation: a Quantitative Analysis Using Transesophageal Echocardiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant; Complications
Keywords: Right ventricular function
Liver transplantation
Transesophageal echocardiography
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2018-03-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cirrhotic patients who underwent a orthotopic liver transplantation

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.

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.

Primary outcomes:
measure: Development of new right ventricular dysfunction during liver transplantation
timeFrame: Through study completion, after 1 year of data retrieval and analysis.
Secondary outcomes:
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Nubia V Figueiredo, MSc, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.