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

NCT07252401 | Not Yet Recruiting

• 1 other identifier: TERLI-AGIB-AKI
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis

Keywords

acute gastrointestinal bleeding; acute kidney injury; terlipressin; somatostatin; liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Duration of AKI

  6 weeks

• Recurrence of AKI

  6 weeks

• Kidney replacement therapy rate

  6 weeks

• Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate

  6 weeks

• Liver and kidney transplantation treatment rate

  6 weeks

Study Arms (2)

Terlipressin group

EXPERIMENTAL

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

Drug: 2-4 mg of terlipressin

Somatostatin group

ACTIVE COMPARATOR

Continuous intravenous infusion of somatostatin 3 mg every 12 hours.

Drug: 3 mg of somatostatin

Interventions

2-4 mg of terlipressin DRUG

Participants receive 2-4 mg of terlipressin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.

Also known as: Terlivaz

Terlipressin group

3 mg of somatostatin DRUG

Participants receive 3 mg of somatostatin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.

Also known as: Stilamin

Somatostatin group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, China

Location

Related Publications (4)

• 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.

  PMID: 32860184 RESULT

• 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.

  PMID: 1350562 RESULT

• 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.

  PMID: 30508958 RESULT

• 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.

  PMID: 38161497 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Acute Kidney Injury

Interventions

Terlipressin; terlivaz; Somatostatin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Pancreatic Hormones

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingshun Qi, MD

CONTACT

18909881019; xingshunqi@126.com

Qianqian Li

CONTACT

13940307473; 1208594776@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 26, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)