The scientific rationale and study protocol for the DPP3, Angiotensin II, and Renin Kinetics in Sepsis (DARK-Sepsis) randomized controlled trial: serum biomarkers to predict response to angiotensin II versus standard-of-care vasopressor therapy in the treatment of septic shock

What Was Tested

Researchers studied Angiotensin II in this clinical study publication.

To determine if the ability to predict vasopressor response is specific to AT2 therapy, the primary analysis will be the ability of baseline renin and DPP3 levels to predict vasopressor response adjusted for treatment arm (AT2 versus control) and Sequential Organ Failure Assessment (SOFA) scores.

Why It Was Studied

Data to support the use of specific vasopressors in septic shock are limited.

Registered on April 24, 2023.

Who Took Part

In both groups, a series of renin and DPP3 levels will be obtained over the first 24 h of treatment with AT2 or SOC.

Secondary outcomes will include rates of acute kidney injury, need for mechanical ventilation and kidney replacement therapy, lengths of stay in the ICU and hospital, ICU and hospital mortality, and rates of prespecified adverse events.

How the Study Was Run

The design is described as randomized, open-label and multicenter.

The participants were allocated by chance, so the Angiotensin II group and the comparison group should start out alike.

Everyone knew when Angiotensin II was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

More than one site took part, so the participants came from several places.

What Was Measured

Topics PubMed links to this paper include Shock, Septic, Angiotensin II, Renin, Vasoconstrictor Agents, Sepsis, Norepinephrine and Biomarkers.

Author keywords: DPP3, Dipeptidyl-peptidase 3, Septic shock and Vasopressor.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Angiotensin II.

The abstract goes on to report its results in about 3 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2024 (Trials), a journal based in England.

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