Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction

Overall, 64 cirrhotic patients with a diagnosis of AVB and RD will be enrolled. Renal dysfunction is defined as serum creatinine (SCr) level >1.5 mg/dl at admission. They will be stratified according to the severity of liver dysfunction (i.e., Child-Pugh class A, B, and C) and degree of SCr level elevation [i.e., 1.5-2mg/dl (133-177 μmol/L), 2-3 mg/dl (177-265 μmol/L), and ≥3 mg/dl (265 μmol/L)], and then randomly assigned to terlipressin group and somatostatin group at a ratio of 1:1. The primary study endpoint is renal function recovery after 5-day treatment. Secondary endpoints include incidence of AKI within 7 days, 5-day failure to control bleeding, requirement of renal replacement therapy, TIPS, liver transplantation, and kidney transplantation within 6 weeks, 6-week mortality, 6-week rebleeding, and incidence of adverse events within 6 weeks.

Inclusion criteria

• patients have a definite diagnosis of live cirrhosis and AVB;
• patients present with renal dysfunction at admission;
• patients' age 18-70 years old;
• patients or relatives can sign the informed consent form.

Exclusion criteria

• patients have non-variceal upper gastrointestinal bleeding;
• patients have hepatorenal syndrome- acute renal injury (HRS-AKI);
• patients have structural kidney injury;
• patients have chronic kidney disease;
• patients received kidney replacement therapy before enrollment;
• patients have a history of liver transplantation or TIPS;
• patients have acute liver failure or acute-on-chronic liver failure;
• patients have hepatic or renal malignant tumor;
• patients have severe diseases of the heart, lungs, and brain;
• patients have contraindications for experimental drugs;
• patients are in pregnancy or lactation;
• patients participated in other clinical studies within 3 months before enrollment;
• patients have other conditions that investigators deem unsuitable for enrollment in the study.