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Acute Renal effects of Angiotensin II Management In Shock in the Intensive Care Unit (ARAMIS-ICU)

A prospective study of the renal effects of angiotensin II management in critically ill patients with distributive shock

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000281897
Acronym
ARAMIS-ICU
Enrollment
160
Registered
2021-03-12
Start date
2021-04-01
Completion date
2021-06-27
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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 prospective study will examine the renal outcomes of critically ill patients with distributive 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 until resolution of their distributive shock. The renal outcomes and survival of patients receiving angiotensin II will be compared to those of control patients who received noradrenaline in the preceding period.

Interventions

Angiotensin II administered continuously via intravenous infusion at a dose range of 5-40 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. Patients in the intervention arm may receive noradrenaline or metaraminol prior to angiotensin II prior to initiation of angiotensin II where this therapy was initiated in the operating theatre, emergency department, or on t

Angiotensin II administered continuously via intravenous infusion at a dose range of 5-40 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. Patients in the intervention arm may receive noradrenaline or metaraminol prior to angiotensin II prior to initiation of 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 noradrenaline or metaraminol prior to enrolment are ineligible for the study.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• 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 criteria

• Cardiac surgery patients • >24 hours noradrenaline or metaraminol prior to enrolment • Chronic haemodialysis or peritoneal dialysis • Not receiving venous thromboembolism prophylaxis • Venous thromboembolism or pulmonary embolus in the last 6 months • Expected survival <24 hours • Suspected or confirmed pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026