Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction

What Was Tested

In this not phased trial, researchers set out to test Somatostatin and Terlipressin.

It had two arms (groups): Terlipressin group (experimental) and Somatostatin group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Overall, 64 cirrhotic patients with a diagnosis of AVB and RD will be enrolled.

The primary study endpoint is renal function recovery after 5-day treatment.

Secondary endpoints include incidence of AKI within 7 days, 5-day failure to control bleeding, requirement of renal replacement therapy, TIPS, liver transplantation, and kidney transplantation within 6 weeks, 6-week mortality, 6-week rebleeding, and incidence of adverse events within 6 weeks.

Who Took Part

64 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients have a definite diagnosis of live cirrhosis and AVB;. Patients present with renal dysfunction at admission;. Patients' age 18-70 years old;. Patients or relatives can sign the informed consent form.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: patients have non-variceal upper gastrointestinal bleeding;; patients have hepatorenal syndrome- acute renal injury (hrs-aki);; patients have structural kidney injury;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Somatostatin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Somatostatin study: the participants and staff both knew the treatment.

It started in 2026-09-25 with completion listed for 2028-03-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Renal function recovery (time frame: 6 weeks).

It also tracked 8 secondary outcomes, for example Incidence of AKI within 7 days, 5-day failure to control bleeding, Kidney replacement therapy rate, Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate, Liver and kidney transplantation treatment rate and 6-week mortality rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Somatostatin and Terlipressin in 64 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Somatostatin compound page and the Terlipressin compound page, all human trials.