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Completed

NCT Number: NCT04050683

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

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.

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Key information

Conditions

Refractory Ascites Ascites Hydrothorax Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Procedure

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.

Other names: Hemodynamic Measurements, Transthoracic Echocardiogram (TTE), Research Blood Tests

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Procedure

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.

Other names: Hemodynamic Measurements, Research Blood Tests

Primary outcomes

  1. 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

  1. Clinical success

    Time frame: 6 months after TIPS placement

    No further need for paracentesis or thoracentesis at 6 months

  2. Overall survival

    Time frame: all patients will be followed for 1 year after TIPS placement

    evaluation of overall survival from time of TIPS placement to death

  3. Complications

    Time frame: 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.

  4. TIPS patency

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

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

Other outcomes

  1. Correlation of cardiac events with laboratory values

    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

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

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Radiological Society of North America

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2019
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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