Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Not yet enrolling

Conditions: Liver Cirrhosis

Treatments: Drug: 2-4 mg of terlipressin; Drug: 3 mg of somatostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT07252401

TERLI-AGIB-AKI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Terlipressin group

Experimental group

Description:

Continuous intravenous infusion of terlipressin 2-4 mg every 12 hours.

Treatment:

Drug: 2-4 mg of terlipressin

Somatostatin group

Active Comparator group

Description:

Continuous intravenous infusion of somatostatin 3 mg every 12 hours.

Treatment:

Drug: 3 mg of somatostatin