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.
Overall, 64 cirrhotic patients with a diagnosis of AGIB and AKI will be enrolled. They will be stratified according to the severity of AKI, and then randomly assigned to terlipressin group and somatostatin group at a ratio of 1:1. The primary endpoint is reversal of AKI after treatment on 5 days. Secondary endpoints include duration of AKI, recurrence of AKI, rates of renal replacement therapy, transjugular intrahepatic portosystemic shunt (TIPS) treatment, liver, and kidney transplantation, 6-week mortality, 6-week rebleeding rate, and incidence of adverse events.
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
Reversal of AKI
The reversal of AKI is defined as clinical symptoms of AKI disappear and serum creatinine (SCr) levels decrease after treatment.
Time frame: 5 days
Duration of AKI
The duration of AKI is defined as the time from occurrence to reversal of AKI.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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