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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04446858

Acronym

NECTAR

Enrollment

1000

Registered

2020-06-25

Start date

2021-01-01

Completion date

2030-07-01

Last updated

2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Acute

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* All patients with portal hypertension and kidney failure

Exclusion criteria

* no consent, no kidney failure, no portal hypertension

Design outcomes

Primary

Measure	Time frame	Description
Survival	up to 10 years	death, liver transplantation

Secondary

Measure	Time frame	Description
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
Liver Failure	up to 10 years	defined as Bilirubin level ≥ 12mg/dl
Ascites	up to 10 years	Evaluation of amount of ascites according to the Child-Score
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
Acute-on-Chronic Liver Failure	up to 10 years	Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria

Countries

Germany

Contacts

Primary ContactMichael Praktiknjo, MD

michael.praktiknjo@ukbonn.de+49(0)228-287 15770

Backup ContactJohannes Chang, MD

johannes.chang@ukbonn.de+49(0)228-287 15770

Outcome results