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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Participants receive 2-4 mg of terlipressin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.
Participants receive 3 mg of somatostatin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China
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.
Time frame: 6 weeks
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.
Time frame: 7 days
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.
Time frame: 5 days
Kidney replacement therapy rate
Participants undergo dialysis or continuous kidney replacement therapy due to failure to recover renal function after treatment.
Time frame: 6 weeks
Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate
Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.
Time frame: 6 weeks
Liver and kidney transplantation treatment rate
Participants undergo liver and kidney transplantation treatment.
Time frame: 6 weeks
6-week mortality rate
The 6-week mortality rate is defined as the all-cause mortality rate over 6 weeks.
Time frame: 6 weeks
6-week rebleeding rate
The 6-week rebleeding rate is defined as the rebleeding rate within 6 weeks after successful AVB hemostasis.
Time frame: 6 weeks
Adverse events
Adverse events will be monitored, including nausea, abdominal pain, diarrhea, arrhythmia, dyspnea, and hyponatremia that may be caused by terlipressin, as well as nausea, abdominal pain, diarrhea, hypoglycemia, and allergies that may be caused by somatostatin. The incidence of adverse events is defined as rate of adverse reactions secondary to terlipressin or somatostatin, endoscopic therapy or interventional procedures during study periods.
Time frame: 6 weeks
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