Vasoactive Drugs in Real World Practice

What Was Tested

In this phase 4 trial, researchers set out to test Somatostatin and Terlipressin.

Various vasoactive drugs are recommended to use in combination with endoscopic variceal ligation (EVL) in treating acute esophageal variceal bleeding (EVB).

It had two arms (groups): somatostatin group (active comparator) and terlipressin group (placebo comparator).

The registry classes the interventions as device and drug.

More on the Plan

Introduction Rupture of esophageal varices that results in variceal hemorrhage is a major complication of cirrhotic patient leading to high mortality rate.

Endoscopic variceal ligation (EVL) is recommended in patients with EVB and is best used in combination with vasoactive drugs according to the Baveno IV consensus.

The management of acute EVB in real world clinical practice may be much different from the recommendation of guidelines.

Nevertheless, the NHI system to date provides only a short-course (3 days) administration of vasoactive drugs in treating acute EBV.

Who Took Part

The registry lists 150 actual participants took part.

It was open to people of any sex aged from 20 years up to 80 years.

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

Examples of who could join: Acute hemorrhage from esophageal varice(s). Portal hypertension attributed by cirrhosis. Age was between 20 and 80 years old.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: with current gastric variceal bleeding; ever underwent endoscopic injection sclerotherapy (eis), evl within 6 month prior to current bleeding episode; ever received shunt or transjugular intrahepatic porto-systemic stent shunt (tips) procedure.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

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

Being open-label, the Somatostatin study did not mask who received what.

It started in 2010-05 with completion listed for 2015-01.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence rate of early rebleeding (time frame: up to 42 days).

It also tracked 3 secondary outcomes, for example Incidence rate of very early rebleeding, Incidence rate of mortality and Percentage of participants with treatment-related adverse effects assessed by CTCAE v4.0.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Somatostatin and Terlipressin in 150 people.

The trial is marked completed; 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.