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NCT04050683·Not applicable·INTERVENTIONAL

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

NesiritideOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

50

Locations

1

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

PROCEDURE

Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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.

PROCEDURE

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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.

Timeline

From registration to results.

  1. First posted

    Aug 8, 2019

  2. Study start

    Sep 25, 2019

  3. Primary completion

    Dec 9, 2024

  4. Study completion

    Dec 9, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Dec 13, 2024

Outcomes

What the study measures.

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

Time frame · 6 months after TIPS placement

No further need for paracentesis or thoracentesis at 6 months

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

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.

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, United States

Publications

Results and literature.

PMID 6977404 ↗Colapinto RF, Stronell RD, Birch SJ, Langer B, Blendis LM, Greig PD, Gilas T. Creation of an intrahepatic portosystemic shunt with a Gruntzig balloon catheter. Can Med Assoc J. 1982 Feb 1;126(3):267-8. No abstract available.PMID 27099653 ↗Ascha M, Abuqayyas S, Hanouneh I, Alkukhun L, Sands M, Dweik RA, Tonelli AR. Predictors of mortality after transjugular portosystemic shunt. World J Hepatol. 2016 Apr 18;8(11):520-9. doi: 10.4254/wjh.v8.i11.520.PMID 24927612 ↗Parvinian A, Bui JT, Knuttinen MG, Minocha J, Gaba RC. Right atrial pressure may impact early survival of patients undergoing transjugular intrahepatic portosystemic shunt creation. Ann Hepatol. 2014 Jul-Aug;13(4):411-9.PMID 11690706 ↗Kiszka-Kanowitz M, Henriksen JH, Moller S, Bendtsen F. Blood volume distribution in patients with cirrhosis: aspects of the dual-head gamma-camera technique. J Hepatol. 2001 Nov;35(5):605-12. doi: 10.1016/s0168-8278(01)00175-1.PMID 30248015 ↗Xu J, Murphy SL, Kochanek KD, Bastian B, Arias E. Deaths: Final Data for 2016. Natl Vital Stat Rep. 2018 Jul;67(5):1-76.PMID 29427496 ↗Marcellin P, Kutala BK. Liver diseases: A major, neglected global public health problem requiring urgent actions and large-scale screening. Liver Int. 2018 Feb;38 Suppl 1:2-6. doi: 10.1111/liv.13682.PMID 16521209 ↗Liu H, Gaskari SA, Lee SS. Cardiac and vascular changes in cirrhosis: pathogenic mechanisms. World J Gastroenterol. 2006 Feb 14;12(6):837-42. doi: 10.3748/wjg.v12.i6.837.PMID 26556983 ↗Ruiz-del-Arbol L, Serradilla R. Cirrhotic cardiomyopathy. World J Gastroenterol. 2015 Nov 7;21(41):11502-21. doi: 10.3748/wjg.v21.i41.11502.PMID 14715521 ↗Luo B, Liu L, Tang L, Zhang J, Ling Y, Fallon MB. ET-1 and TNF-alpha in HPS: analysis in prehepatic portal hypertension and biliary and nonbiliary cirrhosis in rats. Am J Physiol Gastrointest Liver Physiol. 2004 Feb;286(2):G294-303. doi: 10.1152/ajpgi.00298.2003.PMID 21813388 ↗Tsiakalos A, Hatzis G, Moyssakis I, Karatzaferis A, Ziakas PD, Tzelepis GE. Portopulmonary hypertension and serum endothelin levels in hospitalized patients with cirrhosis. Hepatobiliary Pancreat Dis Int. 2011 Aug;10(4):393-8. doi: 10.1016/s1499-3872(11)60066-0.PMID 29971269 ↗Habash F, Gurram P, Almomani A, Duarte A, Hakeem A, Vallurupalli S, Bhatti S. Correlation between Echocardiographic Pulmonary Artery Pressure Estimates and Right Heart Catheterization Measurement in Liver Transplant Candidates. J Cardiovasc Imaging. 2018 Jun;26(2):75-84. doi: 10.4250/jcvi.2018.26.e2. Epub 2018 Jun 22.PMID 19902484 ↗Boyer TD, Haskal ZJ; American Association for the Study of Liver Diseases. The Role of Transjugular Intrahepatic Portosystemic Shunt (TIPS) in the Management of Portal Hypertension: update 2009. Hepatology. 2010 Jan;51(1):306. doi: 10.1002/hep.23383. No abstract available.

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