Acute gastrointestinal bleeding (AGIB) 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 AGIB complicated by acute kidney injury (AKI). 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 AGIB complicated by AKI.
patients have a definite diagnosis of live cirrhosis and AKI;
patients present with AGIB at admission;
patients' age 18-70 years old;
patients or relatives can sign the informed consent form.
patients have hepatorenal syndrome- acute renal injury (HRS-AKI);
patients have structural kidney injury;
patients have chronic kidney disease;
patients received terlipressin or somatostatin therapy within 48 hours before enrollment;
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.
Reversal of AKI
The reversal of AKI is defined as clinical symptoms of AKI disappear and serum creatinine (SCr) levels decrease after treatment.
Duration of AKI
The duration of AKI is defined as the time from occurrence to reversal of AKI.
Recurrence of AKI
Clinical symptoms related to AKI recur and SCr levels increase after the reserval of AKI. The diagnosis of AKI should meet any of the following conditions: an increase in SCr level of ≥0.3 mg/dl (26.5 μmol/L) within 48 hours; or an increase in SCr level to ≥1.5 times the baseline value within 7 days; or urine output \<0.5 ml/kg per hour for a continuous 6 hours.
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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