Hepatorenal Syndrome-acute Kidney Injury (HRS-AKI) Treatment With Transjugular Intrahepatic Portosystemic Shunt in Patients With Cirrhosis. A Randomized Controlled Trial

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study compares the effectiveness and safety of TIPS implantation in patients with HRS-AKI (stage1, 2 and 3) and liver cirrhosis with standard therapy (drug therapy with terlipressin + albumin).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients with cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy and/or blood tests

• Clinically evident ascites due to portal hypertension

• HRS-AKI

• Age: ≥ 18 to ≤ 80 years old at the time of consent

• ECOG \< 4 prior to hospital admission

• Subject has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Ethics Committee (EC) approved consent form.

• Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses). A contraceptive method with a pearl index below 1% is assumed to be effective.

Locations
Other Locations
Germany
University Hospital RWTH Aachen
RECRUITING
Aachen
Charité - Universitätsmedizin Berlin CVK
NOT_YET_RECRUITING
Berlin
University Hospital Dresden, Medical Clinic I, Gastroenterology
RECRUITING
Dresden
Universitätsklinikum Essen (AöR)
NOT_YET_RECRUITING
Essen
University Hospital Freiburg
RECRUITING
Freiburg Im Breisgau
University Hospital Halle
RECRUITING
Halle
University Hospital Hamburg-Eppendorf
RECRUITING
Hamburg
Medical University Hannover
RECRUITING
Hanover
Jena University Hospital, Clinic for Inner Medicine IV
RECRUITING
Jena
Klinikum Landshut AdöR der Stadt Landshut
NOT_YET_RECRUITING
Landshut
University Hospital Leipzig
NOT_YET_RECRUITING
Leipzig
RKH Clinic Ludwigsburg
RECRUITING
Ludwigsburg
Ludwig-Maximilians-University, Klinikum Großhadern
RECRUITING
Munich
University Hospital Münster, Medical Clinic B
RECRUITING
Münster
Contact Information
Primary
Cristina Ripoll, Prof. Dr.
cristina.ripoll@med.uni-jena.de
+4936419
Backup
Alexander Zipprich, Prof. Dr.
alexander.zipprich@med.uni-jena.de
+4936419
Time Frame
Start Date: 2022-11-29
Estimated Completion Date: 2026-06
Participants
Target number of participants: 124
Treatments
Experimental: TIPS group
TIPS implant (transjugular intrahepatic portosystemic shunt)
Active_comparator: Control group
Standard medication therapy with terlipressin and albumin. In the case Terlipressin is not tolerated treatment with Noradrenaline may be considered following actual guidelines.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Halle (Saale), German Research Foundation
Leads: Jena University Hospital

This content was sourced from clinicaltrials.gov