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
Austin Health
150 participants
Oct 21, 2021
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
Inclusion Criteria6
- Adults aged 18+ years
- Vasodilatory shock (MAP <65 mmHg)
- Central venous access and an arterial line present
- Indwelling urinary catheter
- Expected to require vasopressor support for at least 24 hours
- Informed consent provided by the patient or medical treatment decision-maker
Exclusion Criteria6
- Cardiac surgery patients
- >24 hours noradrenaline, metaraminol or vasopressin prior to enrolment
- Chronic haemodialysis or peritoneal dialysis
- Not expected to receive venous thromboembolism prophylaxis in the next 72 hours
- Expected survival <24 hours
- Suspected or confirmed pregnancy
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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 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)
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ACTRN12621001043820