Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903)

What Was Tested

The trial (phase 4) is built around Octreotide and Terlipressin.

Acute variceal bleeding is one of the critical complications in patients with cirrhosis.

It had two arms (groups): Experimental group (experimental) and Control group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Gastroesophageal varices, the most relevant portal-system collaterals, and acute variceal bleeding are critical complications that result directly from portal hypertension in patients with cirrhosis.

Their presence correlates with the severity of liver disease.

Acute variceal bleeding is also responsible for a variety of other complications in patients with cirrhosis including acute on chronic liver failure, hepatorenal syndrome, ascites liquid infection and hepatic encephalopathy.

This cascade of events sets the stage for further renal vasoconstriction and renal sodium retention as the splanchnic and systemic vasodilatation worsens with the progression of cirrhosis.

Who Took Part

The registry lists 60 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: Clinically and/or pathologically diagnosed cirrhosis. With a clinical history of acute variceal bleeding (melena, hematemesis etc.) assessed as Child-Pugh class B or C. Voluntarily participated in the study and able to provide written informed consent and able to understand and willing to comply with the requirements of the study.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: pregnant or lactating woman; diagnosed or suspected malignancy (hepatocellular carcinoma, cholangiocarcinoma etc.); with mental disease and unable to comply with mri examination.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Octreotide was given.

Those kept unaware of assignments: participant.

It started in 2019-07-16 with completion listed for 2020-07-15.

It ran at 10 sites in China (10).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Renal function (time frame: 6 days).

It also tracked 7 secondary outcomes, for example Renal perfusion, Renal blood oxygenation, Failure to control bleeding, Adverse events and Overall survival.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide and Terlipressin in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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