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

May 17, 2022 updated by: Michael Praktiknjo, University Hospital, Bonn

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

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.

Study Overview

Status

Recruiting

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bonn, Germany
        • Recruiting
        • University Hospital Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with portal hypertension and kidney failure are eligible for inclusion

Description

Inclusion Criteria:

  • All patients with portal hypertension and kidney failure

Exclusion Criteria:

  • no consent, no kidney failure, no portal hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
With TIPS
Prospective cohort that received TIPS
Without TIPS
Prospective cohort that did not receive TIPS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

July 1, 2030

Study Completion (ANTICIPATED)

July 1, 2030

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (ACTUAL)

June 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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