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NCT04446858 Clinical Trial

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

Kidney Failure, Acute Clinical Trial

— NECTAR  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04446858
Other study ID # NECTAR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date July 1, 2030

Study information
Verified date May 2022
Source University Hospital, Bonn
Contact Michael Praktiknjo, MD
Phone +49(0)228-287 15770
Email michael.praktiknjo@ukbonn.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date July 1, 2030
Est. primary completion date July 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - All patients with portal hypertension and kidney failure Exclusion Criteria: - no consent, no kidney failure, no portal hypertension

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Bonn Bonn

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

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