Mechanistic Assessment of Norepinephrine Therapy vs. Angiotensin-II in Septic Shock

What Was Tested

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

This trial will determine whether there are better predictors of septic shock severity.

It had two arms (groups): Angiotensin II (experimental) and Norepinephrine (active comparator).

Continuous infusion of Angiotensin II for up to 48 hours.

Continuous infusion of Norepinephrine for up to 48 hours.

The registry classes the interventions as drug.

More on the Plan

This study will determine whether normalization of renin-angiotensin-aldosterone system (RAAS) signaling in sepsis occurs more rapidly with treatment with Angiotensin II compared with conventional vasopressors.

Trial samples will be used to identify the best RAAS biomarker predictor of treatment response via in-depth longitudinal analysis of RAAS component and to determine the extent and mechanisms of Angiotensin II impact on innate immune function during sepsis.

Who Took Part

The registry lists 78 planned participants were the target.

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.

The full record lists 0 inclusion and 10 exclusion criteria; among the exclusions: age \<18 years; pregnant women; patients for whom urgent surgery is anticipated.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Angiotensin II study: the participants and staff both knew the treatment.

It started in 2026-11 with completion listed for 2028-09-30.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Renin Level - Hour 24 (time frame: Hour 24).

It also tracked 69 secondary outcomes, for example Number of Days Without Renal Replacement Therapy, Number of Days of Vasopressor Use, Number of Days Without Mechanical Ventilation, Number of Hours Vasopressor Free, Number of Hours Alive and Number of Days Alive.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Angiotensin II in 78 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.