- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446858
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
Conditions
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
- Name: Michael Praktiknjo, MD
- Phone Number: +49(0)228-287 15770
- Email: michael.praktiknjo@ukbonn.de
Study Contact Backup
- Name: Johannes Chang, MD
- Phone Number: +49(0)228-287 15770
- Email: johannes.chang@ukbonn.de
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NECTAR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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