At a glance
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Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)
In Brief
A clinical study evaluating Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Refractory Ascites. Completed, enrolled 50 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.