Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study

What Was Tested

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

In guidelines norepinephrine is the first line vasopressor recommended in case of septic shock.

Use of vasopressin is recommended when norepinephrine fails to maintain a mean arterial pressure above 65mmHg or in salvage.

It had two arms (groups): one (experimental) and one (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

40 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: Older than 18 years.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: not having terlipressin allergy; not having excipient allergy; A history known for recent acute coronary syndrome (\< 3mois).

How the Study Was Run

It was run as a randomized, parallel-group and double-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 and investigator.

It started in 2018-07-27 with completion listed for 2018-12-01.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Sequential Organ Failure Assessment (SOFA) score difference between the groups (time frame: Day 3).

It also tracked 2 secondary outcomes, for example Mortality rate and Lactates clearance.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Terlipressin in 40 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.