Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 2-4 mg of terlipressin, 3 mg of somatostatin.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury: A Multicenter Randomized Controlled Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Reversal of AKI [Time frame: 5 days]
Secondary outcome measures (8)
- Duration of AKI [Time frame: 6 weeks]
- Recurrence of AKI [Time frame: 6 weeks]
- Kidney replacement therapy rate [Time frame: 6 weeks]
- Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate [Time frame: 6 weeks]
- Liver and kidney transplantation treatment rate [Time frame: 6 weeks]
- 6-week mortality rate [Time frame: 6 weeks]
- 6-week rebleeding rate [Time frame: 6 weeks]
- Adverse events [Time frame: 6 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Gastroenterology, General Hospital of Northern Theater Command (formerly cal — Shenyang
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. PMID 32860184
- 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
- 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
- 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.2 PMID 38161497
Identifiers
NCT: NCT07252401 · TERLI-AGIB-AKI