Terlipressin for Refractory Septic Shock

What Was Tested

In this phase 2 trial, researchers set out to test Terlipressin.

Norepinephrine was recommended as the first vasopressor for septic shock resuscitation.

Vasopressin was also recommended as an alternative vasopressor, in case patient did not response to norepinephrine and or epinephrine.

It had two arms (groups): Terlipressin group (active comparator) and Placebo group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The most common organ ischemia included myocardial ischemia, bowel ischemia and limbs ischemia.

Atrial fibrillation was the most common reported arrhythmia, however, fatal arrhythmia included ventricular fibrillation and tachycardia were also reported.

Vasopressin was recommended as an alternative vasopressor, in case patient did not response to norepinephrine and or epinephrine.

Who Took Part

130 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Septic shock according to Sepsis-3 definition. Evidence of adequate fluid.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: septic shock diagnosis \> 48 hours before; do-not-resuscitation and terminally ill; refractory to treatment malignancy.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind 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.

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

Neither the participants nor the staff measuring them knew who was on Terlipressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-04-03 with completion listed for 2025-03-31.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example 28 day mortality, Mean arterial blood pressure, Hospital mortality and ICU mortality.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Terlipressin in 130 people.

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

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