Angiotensin II for Distributive Shock

What Was Tested

The trial (phase 4) is built around Angiotensin II.

This is a single-center, randomized, double-blind, placebo-controlled pilot study.

A total of 40 patients who develop distributive shock, intra-operatively or post-operatively within 48 hours of heart transplant or left ventricular assist device placement will be enrolled.

Participants will be randomized to Angiotensin II (Giapreza) vs. placebo plus standard of care, as a first line agent for vasoplegia.

It had two arms (groups): Treatment (active comparator) and Control (placebo comparator).

Intravenous (IV) infusion (saline).

The registry classes the interventions as drug.

More on the Plan

Vasoplegia, during or following cardiac surgery, is a life-threatening condition that is characterized by poor organ perfusion and may progress to multi-organ failure.

Catecholamine vasopressors and vasopressin, which are often used as first line vasopressor therapy, are also independent risk factors for end organ dysfunction.

Data comparing mortality with the use of different classes of vasopressors, in various types of shock, have been equivocal to date.

In addition, data comparing the use of different classes of vasopressors for vasoplegia during or after heart transplantation and LVAD implantation are lacking.

Who Took Part

Enrollment: 2 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 (18 years of age or older).

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: patients without distributive shock,; women who are pregnant or breastfeeding; patients who do not receive the study drug as a first line agent for distributive shock.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Angiotensin II 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.

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

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

It started in 2022-06-01 with completion listed for 2024-05-01.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 10 secondary outcomes, for example Time to Extubation, Incidence of Stroke, Incidence of Acute Kidney Injury, Incidence of New Tachyarrhythmia, Units of Blood Transfused and Fluid Overload.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Angiotensin II in 2 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Angiotensin II compound page, all human trials.