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

NCT04050683 | Completed

• 1 other identifier: PRO 35079
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Ascites

Keywords

TIPS; Hemodynamic; Ascites; Hepatic; Hydrothorax

Outcome Measures

Primary Outcomes (1)

• Cardiac related events

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

  from insertion of TIPS to 1 year post TIPS

Secondary Outcomes (4)

• Clinical success

  6 months after TIPS placement

• Overall survival

  all patients will be followed for 1 year after TIPS placement

• Complications

  from insertion of TIPS to 1 year post TIPS

• TIPS patency

  from insertion of TIPS to 1 year post TIPS

Other Outcomes (1)

• Correlation of cardiac events with laboratory values

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

Study Arms (2)

Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

EXPERIMENTAL

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

Procedure: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

ACTIVE COMPARATOR

Normal hemodynamic parameters

Procedure: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Interventions

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.

Also known as: Hemodynamic Measurements, Transthoracic Echocardiogram (TTE), Research Blood Tests

Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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.

Also known as: Hemodynamic Measurements, Research Blood Tests

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Admitted for GI bleed.
• Budd-Chiari syndrome.
• TIPS in setting of mesenteric vein thrombosis.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Radiological Society of North America: collaborator

Study Sites (1)

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (18)

• Strizhakov AN, Lebedev VA. [The current approaches to choosing a rational procedure for the pregnancy and labor management of women with a scar on the uterus]. Akush Ginekol (Mosk). 1991 Feb;(2):8-13. No abstract available. Russian.

  PMID: 1862861 BACKGROUND

• ACR-SIR-SPR Practice Parameter for the Creation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS). :25.

  BACKGROUND

• 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: 27099653 BACKGROUND

• 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: 24927612 BACKGROUND

• 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: 11690706 BACKGROUND

• 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: 30248015 BACKGROUND

• 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: 29427496 BACKGROUND

• Barger IA, Le Jambre LF, Georgi JR, Davies HI. Regulation of Haemonchus contortus populations in sheep exposed to continuous infection. Int J Parasitol. 1985 Oct;15(5):529-33. doi: 10.1016/0020-7519(85)90049-9. No abstract available.

  PMID: 4066146 BACKGROUND

• 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: 26556983 BACKGROUND

• 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: 14715521 BACKGROUND

• 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: 21813388 BACKGROUND

• Ortiz-Muniz G, Sigel MM. Long-term synthesis of antibody in vitro. Proc Soc Exp Biol Med. 1967 Apr;124(4):1178-82. doi: 10.3181/00379727-124-31957. No abstract available.

  PMID: 6024829 BACKGROUND

• 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.

  PMID: 19902484 BACKGROUND

• Hoeper MM, Krowka MJ, Strassburg CP. Portopulmonary hypertension and hepatopulmonary syndrome. Lancet. 2004 May 1;363(9419):1461-8. doi: 10.1016/S0140-6736(04)16107-2.

  PMID: 15121411 BACKGROUND

• Ghaferi AA, Birkmeyer JD, Dimick JB. Complications, failure to rescue, and mortality with major inpatient surgery in medicare patients. Ann Surg. 2009 Dec;250(6):1029-34. doi: 10.1097/sla.0b013e3181bef697.

  PMID: 19953723 BACKGROUND

• Preston SR, Markar SR, Baker CR, Soon Y, Singh S, Low DE. Impact of a multidisciplinary standardized clinical pathway on perioperative outcomes in patients with oesophageal cancer. Br J Surg. 2013 Jan;100(1):105-12. doi: 10.1002/bjs.8974. Epub 2012 Nov 12.

  PMID: 23161343 BACKGROUND

• Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.

  PMID: 9361539 BACKGROUND

• Nevah MI, Kuruvilla AC, Fallon MB. Cardiopulmonary Complications of Cirrhosis. Zakim and Boyer's Hepatology. 7th ed. Philadelphia, PA: Elsevier; 2018 [cited 2018 Dec 22]. p. 281-292.e5.

  BACKGROUND

MeSH Terms

Conditions

Ascites; Hydrothorax

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Eric J Hohenwalter, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor of Radiology, Vascular & Interventional Radiology

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 8, 2019
• Study Start: September 25, 2019
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: During and after (indefinitely) study participation.
• Access Criteria: Participants must have signed the biosample bank consent.

Locations

US (1)