Comparison of Angiotensin II to Standard Dose Vasopressors on Change in Arterial Elastance

What Was Tested

This registered early phase 1 trial tested Angiotensin II.

A study to see whether a medication called Angiotensin II works better than the routinely used medication to raise blood pressure in people with liver disease who are experiencing a serious drop in blood pressure.

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

Angiotensin II will be continued for 24 hours and then discontinued, and SOC vasopressors resumed according to institutional practices.

The registry classes the interventions as drug.

More on the Plan

AII (Angiotensin II) exert its effect after the hydrolysis of Ang-1 by angiotensin converting enzyme (ACE) and is the principal product of the renin-angiotensin-aldosterone system.

The external Ang II administration will be able to reverse the altered Ang (I-7)/Ang II ratio in systemic circulation reversing vasodilation.

Who Took Part

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: Age ≥ 18 years at the time of enrollment. Confirmed cirrhotic patient (Radiological/Biopsy/Physician confirmed).

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: declined consent; CKD-Stage IV/V; ESRD on long-term hemodialysis.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

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.

It started in 2024-11-15 with completion listed for 2028-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in arterial elastance (time frame: 6 hours). Change in arterial elastance (time frame: 24 hours).

It also tracked 11 secondary outcomes, for example Change in arterial ventricular coupling, Change in arterial ventricular coupling, Change in renal perfusion index, Change in renal perfusion index, Evaluation of 28 day renal replacement therapy free survival and Change in Renin levels.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Angiotensin II in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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