Clinical Trial Comparing Noradrenaline (NA) Plus Placebo Versus Noradrenaline Plus Terlipressin (TP) in Septic Shock

What Was Tested

This registered phase 3 trial tested Terlipressin.

Septic shock is a major health problem.

In the clinical practice guidelines of the Surviving Sepsis Campaign is recommended to add vasopressin (VP) or epinephrine in case of not reaching the goal of mean arterial pressure (MAP) although with a low level of evidence.

It had two arms (groups): Noradrenaline plus Terlipressin (experimental) and Noradrenaline plus placebo (placebo comparator).

The registry classes the interventions as combination product.

More on the Plan

Introduction: Septic shock is a major health problem.

The clinical practice guidelines of the Surviving Sepsis Campaign establish the use of NE if after resuscitation with fluids a MAP\> 65 mm Hg is not achieved.

In these guidelines, it is recommended to add VP or epinephrine in case of not reaching the goal of MAP although with a low level of evidence.

TP is a synthetic analogue of VP with a long half-life.

Who Took Part

The registry lists 152 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: Adult patients (18 years or older). Patients with septic shock. Patients with a SOFA \> 4 points.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: pregnant or lactating patients; pathologies in which terlipressin is clinically indicated: gastrointestinal bleeding due to esophageal-gastric varices, hepatorenal syndrome; patients diagnosed with unstable acute coronary syndrome.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.

Those kept unaware of assignments: participant and investigator.

It started in 2022-10-11 with completion listed for 2024-11.

It ran at 10 sites in Spain (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Organ failure (time frame: 72 hours). Days of life free of stay in the Intensive Care Unit (time frame: 28 days).

It also tracked 11 secondary outcomes, for example Lactate clearance, Vasopressor-free days of life, Need of renal replacement therapies, Mechanical ventilation-free days of life, vasopressor index and Mortality.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 152 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.