Serum Biomarkers to Predict Response to Angiotensin II in Septic Shock

What Was Tested

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

Given their angiotensin II will be compared to SOC, this will be an unblinded study.

It had two arms (groups): Angiotensin II (experimental) and Standard of Care (SOC) (no intervention).

The registry classes the interventions as drug.

More on the Plan

Though first-line norepinephrine is standard of care, there are limited prospective data to guide the choice of additional vasopressors in septic shock.

Furthermore, there are no validated biomarkers currently available to guide the choice of vasopressor therapy in septic shock.

In this study the investigators will evaluate two potential biomarkers, renin and dipeptidyl peptidase 3 (DPP3).

A less well-known candidate biomarker is DPP3, which is an aminopeptidase that cleaves a variety of biologically active oligopeptides including angiotensin II.

Who Took Part

Enrollment: 42 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: Patients are required to have central venous and arterial catheters present, and they are expected to remain in place for at least the initial 72 hours of study. Patients are required to have an indwelling urinary catheter present, and it is expected to remain in place for at least the 72 hours of study. Patient or (in patients unable to consent) legal authorized representative (LAR) is willing and able to provide written informed consent and comply with all protocol requirements.

The full record lists 6 inclusion and 21 exclusion criteria; among the exclusions: patients who are \< 18 years of age; patients diagnosed with acute occlusive coronary syndrome requiring intervention and/or cardiogenic shock; patients with or suspected to have abdominal aortic aneurysm or aortic dissection.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Angiotensin II study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2023-04-17 with completion listed for 2025-03-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Ability of Baseline DPP3 to Predict NED at 3 Hours (time frame: 3 hours post drug initiation or SOC equivalent).

It also tracked 1 secondary outcome, for example Hospital Mortality.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Angiotensin II in 42 people.

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.