To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding

What Was Tested

The trial (not phased) is built around Terlipressin.

All patients will be managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac rhythm, pulse rate, blood pressure, and oxygen saturation.

Hemoglobin (Hb) will checked every 6 h for the initial 48 h and then every 12 h till discharge.

It had two arms (groups): Bolus Terlipressin (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 110 actual participants took part.

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: Informed consent to participate in the study. Age 18 to 70 years.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: pregnant and lactation; prior treatment with any vasoactive drugs; hemodynamically unstable.

How the Study Was Run

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

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

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

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

It started in 2016-05-05 with completion listed for 2017-12-10.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Terlipressin related complications in both groups, Rebleed within 42 days, number of blood transfusion requirement at 5 days, Incidence of ischaemic hepatitis within 5 days, Incidence of post bleed acute kidney injury within 5 days and Incidence of post EVL(endoscopic band ligation) ulcer bleed within 5 days.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 110 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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