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

Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Upper Gastrointestinal Bleeding and Renal Dysfunction: A Multicenter Randomized Controlled Trial

Acute upper gastrointestinal bleeding (AUGIB) is a common complication in the decompensated stage of liver cirrhosis, of which approximately 70% is acute variceal bleeding (AVB) caused by portal hypertension. Existing evidence suggests that both terlipressin and somatostatin can be used to control AUGIB in cirrhotic patients, but terlipressin may be the first-line treatment for cirrhotic patients with AUGIB complicated by renal dysfunction (RD). Herein, a multicenter randomized controlled trial (RCT) has been designed to compare the efficacy of terlipressin and somatostatin in the treatment of cirrhotic patients with AUGIB complicated by RD.

Overall, 64 cirrhotic patients with a diagnosis of AUGIB 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 AUGIB;
• 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 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.