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

Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Drug: 2-4 mg of terlipressin; Drug: 3 mg of somatostatin

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xingshun Qi, MD; Phone Number: 18909881019; Email: xingshunqi@126.com
• Study Contact Backup: Name: Qianqian Li; Phone Number: 13940307473; Email: 1208594776@qq.com

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: Xingshun Qi, MD; Phone Number: 18909881019; Email: xingshunqi@126.com
      • Contact: Qianqian Li; Phone Number: 13940307473; Email: 1208594776@qq.com

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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
Reversal of AKI	The reversal of AKI is defined as clinical symptoms of AKI disappear and serum creatinine (SCr) levels decrease after treatment.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of AKI	The duration of AKI is defined as the time from occurrence to reversal of AKI.	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.	6 weeks
Kidney replacement therapy rate	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	Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.	6 weeks
Liver and kidney transplantation treatment rate	Participants undergo liver and kidney transplantation treatment.	6 weeks
6-week mortality rate	The 6-week mortality rate is defined as the all-cause mortality rate over 6 weeks.	6 weeks
6-week rebleeding rate	The 6-week rebleeding rate is defined as the rebleeding rate within 6 weeks after successful AVB hemostasis.	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.	6 weeks

Collaborators and Investigators

• 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

General Publications

• Xu X, Liu B, Lin S, Li B, Wu Y, Li Y, Zhu Q, Yang Y, Tang S, Meng F, Chen Y, Yuan S, Shao L, Bernardi M, Yoshida EM, Qi X. Terlipressin May Decrease In-Hospital Mortality of Cirrhotic Patients with Acute Gastrointestinal Bleeding and Renal Dysfunction: A Retrospective Multicenter Observational Study. Adv Ther. 2020 Oct;37(10):4396-4413. doi: 10.1007/s12325-020-01466-z. Epub 2020 Aug 28.
• Walker S, Kreichgauer HP, Bode JC. Terlipressin vs. somatostatin in bleeding esophageal varices: a controlled, double-blind study. Hepatology. 1992 Jun;15(6):1023-30. doi: 10.1002/hep.1840150609.
• Zhou X, Tripathi D, Song T, Shao L, Han B, Zhu J, Han D, Liu F, Qi X. Terlipressin for the treatment of acute variceal bleeding: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(48):e13437. doi: 10.1097/MD.0000000000013437.
• Xu X, Tang C, Linghu E, Ding H; Chinese Society of Hepatology, Chinese Medical Association; Chinese Society of Gastroenterology, Chinese Medical Association; Chinese Society of Digestive Endoscopy, Chinese Medical Association. Guidelines for the Management of Esophagogastric Variceal Bleeding in Cirrhotic Portal Hypertension. J Clin Transl Hepatol. 2023 Dec 28;11(7):1565-1579. doi: 10.14218/JCTH.2023.00061. Epub 2023 Oct 17.

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2025
• 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): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: acute kidney injury; terlipressin; liver cirrhosis; somatostatin; acute gastrointestinal bleeding
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Diseases; Liver Diseases; Renal Insufficiency; Fibrosis; Pathological Conditions, Signs and Symptoms; Acute Kidney Injury; Liver Cirrhosis; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pancreatic Hormones; Pituitary Hormones, Posterior; Pituitary Hormones; Pituitary Hormone Release Inhibiting Hormones; Vasopressins; Lypressin; Terlipressin; Somatostatin; terlivaz
• Other Study ID Numbers: TERLI-AGIB-AKI

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