Angiotensin II for Septic Shock Treatment

What Was Tested

The trial (phase 3) is built around Angiotensin II.

This study aims to investigate the effect of angiotensin II on microcirculation and peripheral perfusion in patients with septic shock.

It had two arms (groups): Angiotensin group (experimental) and Normal saline group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Shock is a syndrome characterized by acute circulatory failure resulting in impaired peripheral tissue perfusion.

Distributive shock is the most common type of shock and is usually caused by severe sepsis.

The use of vasopressors is an essential management line for distributive sock.

Two groups of vasopressors are usually used for management of shock: catecholamines and vasopressin-like peptides.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Septic shock patients. Aged above 18 years. With cardiac index \> 2.4 L/min/BSA 1.73 m2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: acute coronary syndrome; impaired cardiac contractility; major burns.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Angiotensin II 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 Angiotensin II.

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

It started in 2019-04-01 with completion listed for 2019-08-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean flow index (time frame: 6 Hours).

It also tracked 15 secondary outcomes, for example Proportion of perfused vessels, Perfused vessel density, systolic blood pressure, Diastolic blood pressure, Heart rate and Serum lactate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Angiotensin II in 20 people.

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

Its status is suspended; no results are posted to the registry yet, so nothing here describes outcomes.

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