2-4 mg of terlipressin: Participants 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: Participants receive 3 mg of somatostatin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* 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.
Primary outcome measure(s)
Renal function recovery — 6 weeks 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.
Trial sites (1)
Facility
City
Region
Status
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang
Liaoning
More General Hospital of Shenyang Military Region trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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