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临床试验/NCT03459924
NCT03459924Unknown不适用

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

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年2月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
19
试验地点
1
主要终点
Development of new right ventricular dysfunction during liver transplantation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Development of new right ventricular dysfunction during liver transplantation

时间窗: Through study completion, after 1 year of data retrieval and analysis.

Signs of right ventricular dysfunction as assessed by transesophageal echocardiography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GLAUBER GOUVEA

Principal Investigator

Universidade Federal do Rio de Janeiro

研究点 (1)

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