CompletedPhase 2ACTRN12621000281897

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


Sponsor

Austin Health

Enrollment

200 participants

Start Date

Apr 1, 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 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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

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 Criteria7

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

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

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.


Locations(1)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12621000281897


Related Trials