Angiotensin II vs. Vasopressin in Septic Shock

What Was Tested

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

It had two arms (groups): angiotensin II (intervention) (experimental) and vasopressin (standard of care) (active comparator).

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.

This study is a pilot randomized controlled trial (RCT) comparing AngII (intervention) and vasopressin (standard of care) as second-line vasopressors in septic shock.

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

In this study the investigators will investigate serum renin as such a biomarker.

Who 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: 2\. 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. 3\. 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. 5\. 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: 1\. patients who are \< 18 years of age; 2\. patients diagnosed with acute occlusive coronary syndrome requiring intervention and/or cardiogenic shock; 3\. 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.

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

The Vasopressin group and the comparison group ran side by side rather than switching.

Being open-label, the Vasopressin study did not mask who received what.

It started in 2022-01-03 with completion listed for 2022-11-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of patients who achieve blood pressure (BP) goal (MAP ≥65 mmHg) at 3 hours post-drug initiation (time frame: 3 hours).

It also tracked 14 secondary outcomes, for example BP goal at other time points, Time to shock reversal, SOFA score, Acute Kidney Injury (AKI), Freedom from Renal Replacement Therapy (RRT) and Ventilator-free days.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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