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 AVB in cirrhotic patients, but terlipressin may be the first-line treatment for cirrhotic patients with AVB 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 AVB complicated by RD.
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.
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;
Parallel
2-4 mg of terlipressin
DrugParticipants receive 2-4 mg of terlipressin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.
3 mg of somatostatin
DrugParticipants receive 3 mg of somatostatin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.
Renal function recovery
The renal function recovery is defined as SCr level ≤ 1.5 mg/dl (133 μmol/L) in two consecutive measurements with an interval of at least 2 hours between them.
Incidence of AKI within 7 days
Clinical symptoms related to AKI occur and SCr levels increase after the treatment. The diagnosis of AKI should meet any one of the following conditions: 1) an increase in SCr level of ≥ 0.3 mg/dl (26.5 μmol/L) within 48 hours; 2) an increase in SCr level to ≥ 1.5 times the baseline value within 7 days; 3) a urine output of \< 0.5 ml/kg per hour for a continuous 6 hours.
5-day failure to control bleeding
The 5-day failure to control bleeding is defined as failure to achieve effective control of AVB or occurrence of rebleeding within 5 days after treatment.
Kidney replacement therapy rate
Participants undergo dialysis or continuous kidney replacement therapy due to failure to recover renal function after treatment.
Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate
Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.
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