跳至主要内容
临床试验/NCT04050683
NCT04050683已完成不适用

Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Cardiac related events

研究概览

简要总结

During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the vein above the collarbone in the neck) using fluoroscopy (real time x-rays) guidance. Then, a stent is inserted between the portal vein (vein that carries blood from the intestines into the liver) to a hepatic vein (vein that carries blood away from the liver back to the heart). This means that blood that would usually gets filtered through the liver is now bypassing the liver and going directly to the heart. Because more blood will be flowing to the heart, the heart needs to be strong enough to handle the extra volume.

This study is being done to determine the impact of the TIPS procedure on cardiac (heart) function by collecting data (heart pressures) during the TIPS procedure. Immediately after TIPS and at standard follow-up time points, labs and transthoracic echocardiograms (TTE or echo) will also be collected.

The device(s) used in this study are neither the intervention studied nor the experimental variable of interest. Devices are commercially available and used, and procedures are performed, in accordance with the institution's standard of care.

详细描述

The long-term goal of this proposal is to improve survival in patients with end stage liver disease following TIPS placement. Given that the most common indications for TIPS placement are also defining features of decompensated cirrhosis, specifically hemorrhage and refractory ascites, the overall health of this patient population is extraordinarily complex. One notable circulatory impact of cirrhosis is the increase in total blood volume in concert with a disproportionate increase in splanchnic blood volume. Therefore, at the time of TIPS placement, a patient may experience a marked increase in central blood volume that may lead to cardiac dysfunction. Considering that a central feature of cirrhotic cardiomyopathy is attenuated response to stress, it is conceivable that some perioperative cardiovascular complications could be attributed to the patient's baseline health rather than an isolated effect of the procedure alone. By instituting measures to identify patients that may be at increased risk for an adverse outcome, this proposal hopes to offer a new paradigm for managing TIPS patients in the acute postoperative setting. Therefore, the purpose of this study is to derive better correlates between non-invasive and invasive measurements of cardiac function.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Experimental

Right Atrial Pressure (RAP) ≥ 15mmHg or change in RAP ≥ 10 mmHg or Peak Systolic Right Ventricular (PSRV) Pressure ≥ 46 mmHg

干预措施: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) (Procedure)

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Active Comparator

Normal hemodynamic parameters

干预措施: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) (Procedure)

结局指标

主要结局

Cardiac related events

时间窗: from insertion of TIPS to 1 year post TIPS

any cardiac event to include, heart failure, heart attack, pulmonary hypertension

次要结局

  • Clinical success(6 months after TIPS placement)
  • Overall survival(all patients will be followed for 1 year after TIPS placement)
  • TIPS patency(from insertion of TIPS to 1 year post TIPS)
  • Complications(from insertion of TIPS to 1 year post TIPS)

研究者

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

Eric J. Hohenwalter

MD, Professor of Radiology, Vascular & Interventional Radiology

Medical College of Wisconsin

研究点 (2)

Loading locations...

相似试验