Clinical trial NCT04050683: Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Official title: Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Ascites
Keywords: TIPS
Hemodynamic
Ascites
Hepatic
Hydrothorax
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Radiological Society of North America
First posted: 2019-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients undergoing TIPS will have the following hemodynamic measurements obtained: systolic, diastolic and mean RAP; systolic, diastolic and mean right ventricular pressure (RSV). Peak systolic right ventricular (PSRV) pressure will serve as surrogate for pulmonary artery pressure (PAP). There are 2 groups in this project. Subjects will be enrolled in 1 of the 2 groups based on their heart pressure measurements (high or normal). If a subject does not meet criteria for 1 of the 2 groups, they will not be in the study.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: OVERALL INCLUSION

* ≥ 18 years
* Patients with indications as established by the ACR-SIR-SPR practice parameters::

  * prophylaxis against recurrent variceal bleed in high-risk patients
  * portal hypertensive gastropathy or intestine-opathy
  * refractory ascites
  * hepatic hydrothorax
  * hepatopulmonary syndrome
  * hepatorenal syndrome
  * decompression of portosystemic collaterals prior to abdominal surgical procedures
* Technically successful creation of a TIPS shunt, defined as creation of a portosystemic shunt with post TIPS creation portosystemic gradient of ≤ 12 mmHg

STUDY ARM INCLUSION:

• All patients undergoing elective TIPS who meet at least one of the criteria:

* Right atrial pressure (RAP) ≥ 15mm Hg; OR
* Change in RAP ≥ 10mm Hg; OR
* Peak systolic velocity ratio (PSRV) pressure ≥ 46mm Hg

CONTROL ARM INCLUSION:

• Patients undergoing elective TIPS for control of refractory ascites who do not meet at least one of the criteria outlined above for the study arm.

Historical controls: we will use data collected form our own recent institutional review.

EXCLUSION All patients who do not exhibit alterations in invasive RAP or PRVS measurements as listed in Inclusion Criteria and do not meet criteria for participation as a control subject (i.e. are not undergoing elective TIPS for control of refractory ascites).

Admitted for GI bleed.

Budd-Chiari syndrome.

TIPS in setting of mesenteric vein thrombosis.

Primary outcomes:
measure: Cardiac related events
timeFrame: from insertion of TIPS to 1 year post TIPS
Secondary outcomes:
measure: Clinical success
timeFrame: 6 months after TIPS placement
measure: Overall survival
timeFrame: all patients will be followed for 1 year after TIPS placement
measure: Complications
timeFrame: from insertion of TIPS to 1 year post TIPS
measure: TIPS patency
timeFrame: from insertion of TIPS to 1 year post TIPS
Other outcomes:
measure: Correlation of cardiac events with laboratory values
timeFrame: labs will be obtained at baseline and post TIPS at 1-3 days, 2 weeks +/- 3 days, 4-6 weeks, and 4-6 months
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Eric J Hohenwalter, MD
role: PRINCIPAL_INVESTIGATOR
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