Non-invasive Evaluation of the Predictive Value of CEUS a... | NCT04446858

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

NCT04446858

Sponsor

University Hospital, Bonn

Status

Recruiting

Last Update Posted

May 18, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Kidney Failure, Acute

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jul 1, 2030Estimated

Completion Date

Jul 1, 2030Estimated

First Submitted Date

Jun 22, 2020

First Submission Date that Met QC Criteria

Jun 22, 2020

First Posted Date

Jun 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2022

Last Update Posted Date

May 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With TIPS		Prospective cohort that received TIPS
Without TIPS		Prospective cohort that did not receive TIPS

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Ascites	Evaluation of amount of ascites according to the Child-Score	up to 10 years
Hepatic Encephalopathy	Evaluation of the grade according to the West Haven Criteria

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with portal hypertension and kidney failure

Exclusion Criteria:

no consent, no kidney failure, no portal hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Praktiknjo, MD	Contact	+49(0)228-287 15770		michael.praktiknjo@ukbonn.de
Johannes Chang, MD	Contact	+49(0)228-287 15770		johannes.chang@ukbonn.de

Overall Officials

Name	Affiliation	Role
Michael Praktiknjo, MD	University Hospital, Bonn	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Bonn	Recruiting	Bonn			Germany

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided