Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acut… (NCT07252401) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury
China64 participantsStarted 2025-12-25
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reversal of AKI
Timeframe: 5 days
Trial details
NCT IDNCT07252401
SponsorGeneral Hospital of Shenyang Military Region