Hypotension in the Weaning From Vasopressor Drugs

What Was Tested

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

Although there is consensus in the literature on hemodynamic management of septic shock in the resuscitation phase, the best way to conduct the weaning of vasopressor drugs in the stabilization phase remains open.

The present study aims to study the incidence of hypotension in the weaning phase of vasopressor drugs- norepinephrine and vasopressin.

It had two arms (groups): norepinephrine group (experimental) and vasopressin group (experimental).

Initial suspension of norepinephrine.

Initial suspension of vasopressin.

The registry classes the interventions as other.

More on the Plan

A randomized, open-case clinical trial with 2 arms will be conducted: initial suspension of norepinephrine (norepinephrine group) versus initial vasopressin (vasopressin group).

The selection of patients who will participate in the study will be for convenience.

The randomization of the patients will be done by opaque envelopes 1:1, grouped into blocks, generated by random numbers.

In the intensive care unit, after randomization, patients will be identified by posters, attached to the bed.

Who Took Part

The registry lists 78 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: Patients admitted to the intensive care unit. Patients in need of associated use of norepinephrine and vasopressin.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: patients in whom discontinuation of norepinephrine or vasopressin has been given by decision of the assistant team, from a perspective of prioritizing palliative care; patients using a combination of a third drug, with the effect of predominantly vasopressor - adrenaline.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

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

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

It started in 2022-05-01 with completion listed for 2022-12-01.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of hypotension.

It also tracked 5 secondary outcomes, for example Mortality, Length of stay in intensive care unit, Time of use of the vasoactive drugs, Incidence of arrhythmias and Incidence of hemodialysis.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vasopressin in 78 people.

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.