Vasopressin for Septic Shock Pragmatic Trial

What Was Tested

This registered phase 4 trial tested Vasopressin.

Life-threatening low blood pressure due to a serious infection is called "septic shock." Septic shock is treated with vasopressors, medications that raise blood pressure.

Sometimes first-line vasopressors are inadequate, prompting addition of a second-line vasopressor called vasopressin.

However, the threshold at which to start vasopressin remains unclear.

It had two arms (groups): Septic shock treatment strategy involving a lower threshold for vasopressin initiation (active comparator) and Septic shock treatment strategy involving a higher threshold for vasopressin initiation (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

3959 actual participants took part.

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: Age ≥18 years. Admitted to a study hospital emergency department (ED) or inpatient care unit. Administration of vasopressor(s) for septic shock.

The full record lists 3 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and single-blind.

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

In the crossover set-up each of the participants took both Vasopressin and the comparison in turn, acting as their own control.

Only one side, usually the participants, was kept unaware of whether Vasopressin was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2024-02-01 with completion listed for 2026-02-17.

It ran at 13 sites in United States (13).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 28-day all-cause mortality (time frame: 28 days).

It also tracked 1 secondary outcome, for example Renal replacement therapy-free days to day 28.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vasopressin in 3959 people.

With 3959 participants it is a large trial for this field.

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

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