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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hepatorenal Syndrome
• Kidney Failure, Acute
• Renal Insufficiency

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