Methods of analysis
AKI, heart failure, death
RECURRENCE, ACUTE ON CHRONIC LIVER FAILURE, SECONDARY, HEPATIC ENCEPHALOPATHY, REGRESSION, EVENTS, HEART FAILURE, ISCHEMIC HEPATITIS
All compiled data will be analyzed at least in a descriptive manner. Including count of compiled data and missings, mean, standard deviation, minimum, quartiles, and maximum for metric and frequency analysis for ordinal and categorical data.Demography: age, sex, size, weight, racial background.We hypothesize that the 12-month liver transplant-free survival is higher in patients in the interventional group. We will test the hypothesis
The primary endpoint will be analyzed based on the intention to treat principle using a Cox regression adjusted for the AKI stage.We will perform a competing-risk analysis in addition to the primary endpoint with the competing events of death and liver transplantation. As secondary outcomes reversal of HRS-AKI (vs baseline), partial response to treatment (vs baseline), need of renal replacement therapy, and recurrence of HRS-AKI at 3 and 12 months will be assessed by logistic regression adjusted for AKI stage. In-hospital, 28-day, and 90-day survival will be assessed by logistic regression adjusted for AKI stage. Changes in HrQoL at 3 and 12 months with respect to study baseline will be compared between groups by linear regression adjusted for AKI stage. Three-month liver transplant-free survival will be analyzed using a Cox regression adjusted for AKI stage. Development of further decompensations and length of in-hospital stay will be analyzed descriptively. Results will be interpreted in an exploratory manner.The number of AEs and SAEs in each group with special attention on the development of ischemic hepatitis, acute on chronic liver failure, hepatic encephalopathy, and signs of heart failure will be analyzed. Laboratory assessments including sodium, potassium, ALAT, ASAT, GGT, AP, bilirubin, albumin, and INR will be analyzed descriptively as safety parameters.