Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study

What Was Tested

This registered phase 1 trial tested Angiotensin II.

The investigators propose a 20 patient, randomized, placebo-controlled, blinded study in the treatment of high-output shock.

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

Control patients will receive placebo intravenously equal in duration, color and volume to the intervention arm's angiotensin II.

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Cardiovascular SOFA score of \> 4. Cardiac Index \> 2.4 liters/min/BSA 1.73m2. Indwelling arterial line already present as part of standard care. Age \> 21 years of age. Signed consent form.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: patients with acute coronary syndrome; patients with a known history of vasospasm; patients with a history of asthma.

How the Study Was Run

Design: 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.

Neither the participants nor the staff measuring them knew who was on Angiotensin II, so expectations could not easily colour the readings.

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

It started in 2011-07 with completion listed for 2014-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Mortality.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Angiotensin II in 20 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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