Non-invasive Evaluation of the Predictive Value of CEUS and SWE in ACLF, Renal Failure and Hepatorenal Syndrome

Study Overview
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Brief Summary
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Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt (TIPS). Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

Detailed Description
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NECTAR consists of patients with ACLF and renal failure with and without receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.

Official Title
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Non-invasive Evaluation of the Predictive Value of CEUS and SWE in Patients With and Without TIPS With ACLF, Renal Failure and Hepatorenal Syndrome

Conditions
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Kidney Failure, Acute

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with portal hypertension and kidney failure Exclusion Criteria: no consent, no kidney failure, no portal hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With TIPS<br>Prospective cohort that received TIPS | |
| Without TIPS<br>Prospective cohort that did not receive TIPS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | death, liver transplantation | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ascites | Evaluation of amount of ascites according to the Child-Score | up to 10 years | 
| Hepatic Encephalopathy | Evaluation of the grade according to the West Haven Criteria | up to 10 years | 
| Variceal Bleeding | Assessment of presence of variceal bleeding | up to 10 years | 
| Liver Failure | defined as Bilirubin level ≥ 12mg/dl | up to 10 years | 
| Acute-on-Chronic Liver Failure | Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria | up to 10 years | 
| Kidney Failure | Assessment of AKI according to KDIGO | up to 10 years | 
| Organ Failures | Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score | up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transjugular intrahepatic portosystemic shunt (TIPS), non-invasive assessments, circulating biomarkers, Transthoracic echocardiography (TTE) with Speckle-tracking, Elastography, Contrast-enhanced ultrasound, Computer tomography scan (CT-scan), Magnetic resonance imaging (MRI), Urine biomarker