RecruitingPhase 2ACTRN12621001043820

Acute Renal effects of Angiotensin II Management In Shock (ARAMIS-2)

A phase 2b randomised controlled trial of the renal effects of angiotensin II versus noradrenaline in critically ill patients with vasodilatory shock


Sponsor

Austin Health

Enrollment

150 participants

Start Date

Oct 21, 2021

Study Type

Interventional

Conditions

Summary

Angiotensin II is an endogenous peptide that causes potent vasoconstriction and promotes the release of aldosterone from the zona granulosa of the adrenal gland. The ATHOS-3 study demonstrated that continuous infusion of angiotensin II could effectively augment mean arterial pressure compared to placebo in patients with catecholamine refractory shock. Secondary analyses suggested that angiotensin II may be of particular benefit in patients with acute kidney injury, especially in those with a high ratio of angiotensin I to II. This randomised controlled trial will examine the renal outcomes of critically ill patients with vasodilatory shock who receive angiotensin II compared to noradrenaline. Patients who meet all of the inclusion criteria and none of the exclusion criteria will receive a continuous intravenous infusion of angiotensin II or noradrenaline until resolution of their shock. The renal outcomes and survival of patients receiving angiotensin II will be compared to those of control patients who received noradrenaline.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase 2 randomised controlled trial (ARAMIS-2) is testing whether angiotensin II — a naturally occurring hormone that constricts blood vessels — can improve kidney outcomes in critically ill patients with vasodilatory shock. Vasodilatory shock occurs when blood vessels throughout the body become dangerously dilated (often in sepsis), causing blood pressure to fall so low that organs like the kidneys are not getting enough blood flow. Current treatment relies on drugs like noradrenaline to squeeze the blood vessels. Previous research suggested that angiotensin II may be particularly beneficial for patients who already have acute kidney injury. Patients in the ICU with vasodilatory shock will be randomly assigned to receive either angiotensin II or noradrenaline via continuous IV infusion until their shock resolves. Kidney function and survival outcomes will be closely compared between the two groups. To be eligible, you must be an adult (18 or older) in the ICU with low blood pressure from vasodilatory shock, have central IV access and a urinary catheter in place, and be expected to need blood pressure support for at least 24 hours. Patients who are post-cardiac surgery, have been on noradrenaline for more than 24 hours before enrolment, are on permanent dialysis, or are pregnant are not eligible. The study is run by the University of Queensland.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Angiotensin II administered continuously via intravenous infusion at a dose range of 1.25-40 ng/kg/min, with the administered dose titrated to achieve a MAP >65 until resolution of shock or for a maxi

Angiotensin II administered continuously via intravenous infusion at a dose range of 1.25-40 ng/kg/min, with the administered dose titrated to achieve a MAP >65 until resolution of shock or for a maximum of 7 days. After 7 days, patients will be transitioned to noradrenaline as per hospital protocol. Patients in the intervention arm may receive noradrenaline, metaraminol, and/or vasopressin prior to angiotensin II where this therapy was initiated in the operating theatre, emergency department, or on the ward prior to ICU transfer. However, patients who have received >24 hours of an alternative vasopressor prior to enrolment are ineligible for the study. Adherence to the intervention will be monitored using the electronic heart record.


Locations(9)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

The Alfred - Melbourne

VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

VIC, Australia

Flinders Medical Centre - Bedford Park

VIC, Australia

Princess Alexandra Hospital - Woolloongabba

VIC, Australia

Nepean Hospital - Kingswood

VIC, Australia

Caboolture Hospital - Caboolture

VIC, Australia

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ACTRN12621001043820