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

Recruiting

• Conditions: Kidney Failure, Acute

• Registration Number: NCT04446858
• Lead Sponsor: University Hospital, Bonn

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-25
• Study Start: 2021-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18
• Primary Completion: 2030-07-01
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All patients with portal hypertension and kidney failure

Exclusion Criteria

• no consent, no kidney failure, no portal hypertension

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	up to 10 years	death, liver transplantation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Bonn; 🇩🇪 Bonn, Germany