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

Primary Purpose

Refractory Ascites

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

About this trial

This is an interventional diagnostic trial for Refractory Ascites focused on measuring TIPS, Hemodynamic, Ascites, Hepatic, Hydrothorax

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

OVERALL INCUSION

≥ 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.

Sites / Locations

Medical College of Wisconsin/Froedtert Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Arm Description

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

Normal hemodynamic parameters

Outcomes

Primary Outcome Measures

Cardiac related events

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

Secondary Outcome Measures

Clinical success

No further need for paracentesis or thoracentesis at 6 months

Overall survival

evaluation of overall survival from time of TIPS placement to death

Complications

Any peri or post procedural TIPS related events including liver failure, need for re-intervention, etc.

TIPS patency

evaluation of how long the TIPS remains patent without need for further intervention

Full Information

NCT ID

NCT04050683

First Posted

August 7, 2019

Last Updated

March 27, 2023

Sponsor

Medical College of Wisconsin

Collaborators

Radiological Society of North America

1. Study Identification

Unique Protocol Identification Number

NCT04050683

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

September 25, 2019 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

Collaborators

Radiological Society of North America

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Ascites

Keywords

TIPS, Hemodynamic, Ascites, Hepatic, Hydrothorax

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Arm Type

Experimental

Arm Description

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

Arm Title

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Arm Type

Active Comparator

Arm Description

Normal hemodynamic parameters

Intervention Type

Procedure

Intervention Name(s)

Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Other Intervention Name(s)

Hemodynamic Measurements, Transthoracic Echocardiogram (TTE), Research Blood Tests

Intervention Description

Prior to and 1-3 days after the TIPS procedure, the following blood tests are done for research purposes: Brain Natriuretic Peptide (BNP); Endothelin-1; Tumor Necrosis Factor-alpha (TNF-a); Endothelial Nitric Oxide Synthase (eNOS). Subjects with abnormal heart pressures during TIPS will have a right heart catheterization (RHC) to monitor heart function, blood flow, and pressures in and around the heart. The subject will be admitted to the Cardiovascular Intensive Care Unit and have a TTE all of which are standard of care. Routine follow-up visits will occur in IR Clinic at 2 Weeks (± 3 days), 4-6 weeks and 4-6 months. Visits will include: blood draws for research related blood tests as listed above; standard of care ultrasound of the abdomen; TTEs; and for at least one year, routine lab testing, imaging, medications, and subject overall condition will be assessed for long term outcomes. Diagnostic RHC will be done as needed per standard of care.

Intervention Type

Procedure

Intervention Name(s)

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Other Intervention Name(s)

Hemodynamic Measurements, Research Blood Tests

Intervention Description

Subject's with normal heart pressures who are having elective (planned in advance and not due to an emergency) TIPS due to refractory ascites (fluid build up in the belly that does not go away or comes back shortly after being removed). Prior to and 1-3 days after the TIPS procedure, the following blood tests are done for research purposes: Brain Natriuretic Peptide (BNP); Endothelin-1; Tumor Necrosis Factor-alpha (TNF-a); Endothelial Nitric Oxide Synthase (eNOS). The subject will be admitted to the hospital after TIPS for standard of care monitoring. Routine follow-up visits will occur in IR Clinic at 2 Weeks (± 3 days), 4-6 weeks and 4-6 months. Visits will include: blood draws for research related blood tests as listed above; standard of care ultrasound of the abdomen; and for at least one year, routine lab testing, imaging, medications, and subject overall condition will be assessed for long term outcomes.

Primary Outcome Measure Information:

Title

Cardiac related events

Description

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

Time Frame

from insertion of TIPS to 2 years post TIPS

Secondary Outcome Measure Information:

Title

Clinical success

Description

No further need for paracentesis or thoracentesis at 6 months

Time Frame

6 months after TIPS placement

Title

Overall survival

Description

evaluation of overall survival from time of TIPS placement to death

Time Frame

all patients will be followed for 2 years after TIPS placement

Title

Complications

Description

Any peri or post procedural TIPS related events including liver failure, need for re-intervention, etc.

Time Frame

from insertion of TIPS to 2 years post TIPS

Title

TIPS patency

Description

evaluation of how long the TIPS remains patent without need for further intervention

Time Frame

from insertion of TIPS to 2 years post TIPS

Other Pre-specified Outcome Measures:

Title

Correlation of cardiac events with laboratory values

Description

correlations will be made between outcome BNP, TNF-a, eNOS, endothelin-1

Time Frame

labs will be obtained at baseline and post TIPS at 1-3 days, 2 weeks +/- 3 days, 4-6 weeks, and 4-6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric J Hohenwalter, MD

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical College of Wisconsin/Froedtert Hospital

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Participants must have agreed to banking of biosamples. Identified individual participant data for all primary and secondary outcome measures will be made available. Also, left-over research related blood samples will be retained in an IRB approved bank.

IPD Sharing Time Frame

During and after (indefinitely) study participation.

IPD Sharing Access Criteria

Participants must have signed the biosample bank consent.

Citations:

PubMed Identifier

6977404

Citation

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

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