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

NCT ID: NCT07252401

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-25
• Study Completion Date: 2028-03-31

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.

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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Terlipressin group

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

Group Type: EXPERIMENTAL

2-4 mg of terlipressin

Intervention Type: DRUG

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

Somatostatin group

Continuous intravenous infusion of somatostatin 3 mg every 12 hours.

Group Type: ACTIVE_COMPARATOR

3 mg of somatostatin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Terlivaz; Stilamin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Xingshun Qi

Director of Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingshun Qi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, General Hospital of Northern Theater Command

Qianqian Li

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, General Hospital of Northern Theater Command

Rong Li

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, General Hospital of Northern Theater Command

Locations

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

Shenyang, Liaoning, China

Countries

China

Central Contacts

Xingshun Qi, MD

Role: CONTACT

xingshunqi@126.com

18909881019

Qianqian Li

Role: CONTACT

1208594776@qq.com

13940307473

Facility Contacts

Xingshun Qi, MD

Role: primary

xingshunqi@126.com

18909881019

Qianqian Li

Role: backup

1208594776@qq.com

13940307473

References

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.

Reference Type: RESULT

PMID: 32860184 (View on PubMed)

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.

Reference Type: RESULT

PMID: 1350562 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30508958 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38161497 (View on PubMed)

Other Identifiers

TERLI-AGIB-AKI

Identifier Type: -

Identifier Source: org_study_id