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

Not Applicable

Completed

• Conditions: Refractory Ascites
• Interventions: Procedure: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS); Procedure: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

• Registration Number: NCT04050683
• Lead Sponsor: Medical College of Wisconsin

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 Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Study Start: 2019-09-25
• Status Verified: 2024-12
• Primary Completion: 2024-12-09
• Study Completion: 2024-12-09
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)	Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)	Right Atrial Pressure (RAP) ≥ 15mmHg or change in RAP ≥ 10 mmHg or Peak Systolic Right Ventricular (PSRV) Pressure ≥ 46 mmHg
Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)	Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)	Normal hemodynamic parameters

Primary Outcome Measures

Name	Time	Method
Cardiac related events	from insertion of TIPS to 1 year post TIPS	any cardiac event to include, heart failure, heart attack, pulmonary hypertension

Secondary Outcome Measures

Name	Time	Method
Complications	from insertion of TIPS to 1 year post TIPS	Any peri or post procedural TIPS related events including liver failure, need for re-intervention, etc.
Clinical success	6 months after TIPS placement	No further need for paracentesis or thoracentesis at 6 months
Overall survival	all patients will be followed for 1 year after TIPS placement	evaluation of overall survival from time of TIPS placement to death
TIPS patency	from insertion of TIPS to 1 year post TIPS	evaluation of how long the TIPS remains patent without need for further intervention

Trial Locations

Locations (1)

Medical College of Wisconsin/Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States