Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction

August 25, 2026 updated by: Xingshun Qi, General Hospital of Shenyang Military Region

Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction: A Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Terlipressin group
Continuous intravenous infusion of terlipressin 2-4 mg every 12 hours.
Drug: 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.
Other Names:
  • Terlivaz
Active Comparator: Somatostatin group
Continuous intravenous infusion of somatostatin 3 mg every 12 hours.
Drug: 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.
Other Names:
  • Stilamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function recovery
Time Frame: 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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kidney replacement therapy rate
Time Frame: 6 weeks
Participants undergo dialysis or continuous kidney replacement therapy due to failure to recover renal function after treatment.
6 weeks
Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate
Time Frame: 6 weeks
Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.
6 weeks
Liver and kidney transplantation treatment rate
Time Frame: 6 weeks
Participants undergo liver and kidney transplantation treatment.
6 weeks
6-week mortality rate
Time Frame: 6 weeks
The 6-week mortality rate is defined as the all-cause mortality rate over 6 weeks.
6 weeks
6-week rebleeding rate
Time Frame: 6 weeks
The 6-week rebleeding rate is defined as the rebleeding rate within 6 weeks after successful AVB hemostasis.
6 weeks
Incidence of AKI within 7 days
Time Frame: 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.
7 days
Adverse events
Time Frame: 6 weeks
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.
6 weeks
5-day failure to control bleeding
Time Frame: 5 days
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.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Shenyang Military Region

Investigators

  • Principal Investigator: Xingshun Qi, MD, Department of Gastroenterology, General Hospital of Northern Theater Command
  • Principal Investigator: Qianqian Li, Department of Gastroenterology, General Hospital of Northern Theater Command
  • Principal Investigator: Rong Li, Department of Gastroenterology, General Hospital of Northern Theater Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 25, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TERLI-AVB-RD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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