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Clinical Trials/NCT04050683
NCT04050683CompletedNot Applicable

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

Medical College of Wisconsin2 sites in 1 country50 target enrollmentStarted: September 25, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Cardiac related events

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

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

Intervention: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) (Procedure)

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Active Comparator

Normal hemodynamic parameters

Intervention: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) (Procedure)

Outcomes

Primary Outcomes

Cardiac related events

Time Frame: from insertion of TIPS to 1 year post TIPS

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eric J. Hohenwalter

MD, Professor of Radiology, Vascular & Interventional Radiology

Medical College of Wisconsin

Study Sites (2)

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