Renin and Renal Biomarker Response to Angiotensin II

What Was Tested

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

Septic shock continues to exert a large economic burden around the world.

Several developments have occurred that lead to the current study.

First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock.

It had two arms (groups): Standard of Care Cohort (active comparator) and Angiotensin II Cohort (experimental).

Patients in this group will receive standard of care treatment.

Patients in this group will receive angiotensin II.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 30 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: Medical ICU admission.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: acute occlusive coronary syndrome requiring intervention or acute myocardial infarction of any degree; purely cardiogenic shock (no distributive component); mesenteric ischemia.

How the Study Was Run

The set-up was non-randomized, sequential and open-label.

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

It started in 2020-10-19 with completion listed for 2023-07-24.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Plasma Renin Levels (time frame: Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)).

It also tracked 7 secondary outcomes, for example Change in Plasma Cystatin C, Days to Discontinuation of Catecholamines, ICU Length of Stay, Number of Participants With In-hospital Mortality, Renal Replacement Therapy-free Days and Number of Participants Experiencing Prespecified Safety Outcomes.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Angiotensin II in 30 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.