Outcomes {12}
ascites, bleeding, cirrhosis-associated complications, cirrhosis, nephropathy, AKI, variceal bleeding, TIPS
ASCITES, BLEEDING, DECOMPENSATED CIRRHOSIS, CHRONIC LIVER DISEASE, ADVERSE EVENTS, CIRRHOSIS, ACUTE ON CHRONIC LIVER FAILURE, DILUTIONAL HYPONATREMIA, SECONDARY, HEPATIC ENCEPHALOPATHY, NEPHROPATHY, COMPLICATIONS
The primary endpoint is the 12-month liver transplant-free survival. This endpoint has been recently recommended as the primary endpoint to be reported in trials in decompensated cirrhosis [Secondary endpoints include:Reversal of HRS-AKI at 3 and 12 months (vs baseline), defined as the return of serum creatinine level within 0.3 mg/dl (26 µmol/L).Partial response to treatment at 3 and 12 months (vs baseline), defined as reduction of at least one AKI stage with decrease of serum creatinine to ≥ 0.3 mg/dl (26 µmol/L) above the baseline value.3-month liver transplant-free survivalIn-hospital, 28-day, and 90-day survivalDevelopment of cirrhosis-associated complications (further decompensation) during follow-up: overt hepatic encephalopathy, refractory or recurrent ascites, dilutional hyponatremia, new AKI-HRS, variceal bleedingRequirement of TIPS implantation or TIPS revision during follow-up. The accepted indications for TIPS implantation/revision arePre-emptive TIPS for variceal bleeding in patients with Child–Pugh C cirrhosis (≤ 13 points) or Child–Pugh B > 7 points cirrhosis with active bleeding at endoscopyRecurrence of variceal bleeding in Child–Pugh A or B 7 points patients or Child–Pugh B patients without active bleeding at endoscopy despite adequate secondary prophylaxis with beta-blockers and endoscopic band ligationRefractory ascites—this diagnosis can only be established if the patient is in a stable situation without complications such as bleeding and infectionRecurrent ascites—this diagnosis can only be established if the patient is in a stable situation without complications such as bleeding and infectionAdditionally, TIPS revision can be undertaken if there is a clinical suspicion of TIPS dysfunctionDevelopment of acute on chronic liver failure (ACLF) during follow-upLength of in-hospital-stayRelative changes in HrQoL (as measured by SF36 and Chronic Liver Disease Questionnaire (CLDQ)) at 3 and 12 months (vs. baseline)The incidence of adverse events in the TIPS patients compared to standard of care (with specific focus on ACLF and heart failure)Need for renal replacement therapyRecurrence of HRS-AKI after treatment at 3 and 12 monthsImpact of the presence of intrinsic nephropathy as assessed by cystatin C and Urine neutrophil gelatinase-associated lipocalin (UnGAL) on outcomesAssociation of pathophysiological mechanisms of cirrhosis with outcomes (in further studies)