Angiotensin II for Post Cardiac Surgery Vasoplegia (ANGII_V)

What Was Tested

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

The goal of this study is to conduct a prospective trial implementing a modified version of the Emory Protocol for administering ANG II to patients with post cardiac bypass vasoplegia.

Researchers will compare outcomes from the interventional group to historical controls who did not receive Ang II using the modified protocol.

It had two arms (groups): Ang II Administration using a modified Emory protocol (experimental) and one (no intervention).

Historical controls will be extracted from EMR and selected based on 1:1 matching with patients in experimental arm. Matching will be based on a number of factors. Descriptive and comparative analyses will be conducted.

The registry classes the interventions as drug.

More on the Plan

Giapreza is a synthetic human Ang II treatment which acts as a RAAS pathway regulator to rais MAP in adults.

This will be a single center study comparing patients treated with a modified Emory protocol to historical controls who have not received Ang II.

The researchers will observe the effects of using a modified version of the Emory protocol, which includes lowering the dosages needed for norepinephrine and vasopressin.

Additionally, clinicians will administer Ang II prior to starting methylene blue, a drug that poses more risk to patients than Ang II.

Who Took Part

The registry lists 329 planned participants were the target.

It was open to people of any sex aged from 18 years up to 94 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: In order to be eligible to participate in this study, an individual must meet all of the following criteria:. Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, aged 18 or over. Exhibiting vasoplegia or vasoplegic shock following surgeries involving cardiopulmonary bypass.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: an individual who meets any of the following criteria will be excluded from participation in this study:; current use of angiotensin converting enzyme (ace) inhibitors or angiotensin ii receptor blockers (arbs); pregnancy or lactation.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

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

It started in 2026-07 with completion listed for 2029-07.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mortality (time frame: 365 days).

It also tracked 3 secondary outcomes, for example Mean Arterial Pressure, Length of Stay and Length of Stay.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Angiotensin II in 329 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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