| Pre-screening within SoC/confirmation of HRS-AKI diagnosis | Screening/baseline | FU days 1–5 | FU days 12 and 19 | FU day 30 (1 MFU) | FU 2 months (2 MFU) | FU 3 months (3 MFU) | FU 6 and 9 months (6 MFU, 9 MFU) | FU 12 months (12 MFU) | |
|---|---|---|---|---|---|---|---|---|---|
| Medical history/anamnesisa | X | X | |||||||
| Demographic data | X | ||||||||
| Physical examinationb | X | X | X | X | X | X | X | X | X |
| Routine laboratory examinationc | X | X | X | X | X | X | X | X | X |
| 24-h urine | X | X | |||||||
| uETG/alcohol consumption | X | X | X | X | X | X | X | ||
| Echocardiography | X | ||||||||
| Abdominal ultrasound | X | X | X | X | |||||
| Diagnostic paracentesis | X | ||||||||
| Chest-X-ray | X | ||||||||
| Inclusion/exclusion criteria | X | ||||||||
| ICF | X | ||||||||
| Randomization | X | ||||||||
| Blood and urine sampling | X | X (D3) | X | X | X | X | |||
| Optional ascites sampling | X | X (D3) | X | X | X | X | |||
| Optional stool sampling | X | X | X | X | |||||
| Terlipressin/albumin treatmentd | X | # | |||||||
| TIPS | X | Angioe | |||||||
| HrQoL Questionnaires (SF-36, CLDQ) | X | X | X | ||||||
| AE/SAEs | X | ||||||||
| Length of in-hospital stay | X | ||||||||
| Liver transplantation performed | X | ||||||||
| Requirement of renal replacement therapy | X | ||||||||
aMedical history/anamnesis includes questions on the occurrence of HCC, medication intake, actual status of HRS-AKI/ascites (previous and actual therapies/measures, decompensation), and intake of low-salt diet.
bPhysical examination includes evaluation of orientation (time, person, place) and presence of flapping tremor and evaluation of skin, heart, and lung auscultation; abdominal physical examination; and presence of lower limb edema.
cLaboratory values (assessed by local lab): (1) in blood: creatinine, sodium, potassium, ALAT, ASAT, GGT, AP, bilirubin, albumin, CRP, INR, hemoglobin, hematocrit, leukocytes, platelets; (2) in ascites/pleural effusion: albumin, leukocytes, neutrophils, glucose, LDH, bilirubin.
dFor test arm until TIPS placement and then will be progressively discontinued according to the managing physician’s decision. For SoC arm, the treatment will be given beyond baseline (#) and continued according to the Clinical Practice Guidelines and the managing physician’s decision.
eControl angiography within 72 h after TIPS placement (measurement should be performed after pausing Terlipressin for at least 6 h).