NCT04446858

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jan 2021Jul 2030

First Submitted

Initial submission to the registry

June 22, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

9.5 years

First QC Date

June 22, 2020

Last Update Submit

May 17, 2022

Conditions

Kidney Failure, Acute

Keywords

transjugular intrahepatic portosystemic shunt (TIPS)non-invasive assessmentscirculating biomarkersTransthoracic echocardiography (TTE) with Speckle-trackingElastographyContrast-enhanced ultrasoundComputer tomography scan (CT-scan)Magnetic resonance imaging (MRI)Urine biomarker

Outcome Measures

Primary Outcomes (1)

  • Survival

    death, liver transplantation

    up to 10 years

Secondary Outcomes (7)

  • Ascites

    up to 10 years

  • Hepatic Encephalopathy

    up to 10 years

  • Variceal Bleeding

    up to 10 years

  • Liver Failure

    up to 10 years

  • Acute-on-Chronic Liver Failure

    up to 10 years

  • +2 more secondary outcomes

Study Arms (2)

With TIPS

Prospective cohort that received TIPS

Without TIPS

Prospective cohort that did not receive TIPS

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All patients with portal hypertension and kidney failure

You may not qualify if:

  • no consent, no kidney failure, no portal hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, urine, ascites, stool, DNA, PBMC, Buffi coat

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michael Praktiknjo, MD

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Praktiknjo, MD

CONTACT

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

Johannes Chang, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 25, 2020

Study Start

January 1, 2021

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

DE(1)