NCT06693726PHASE4Recruiting

Early Angiotensin II in the Emergency Department

Brett A Faine

Start Date

4/1/2025

Completion Date

11/30/2026

Summary

This pilot study will enroll 20 patients with septic shock and require emergent vasopressor support in the emergency department (ED). The primary objective of the study is to determine the feasibility of early peripheral administration of angiotensin II for treatment of septic shock in the ED

Detailed Description

Following informed consent, patients will receive intravenous angiotensin II (AT-II) infusion for blood pressure support. The patient will remain on the AT-II infusion for 60 minutes prior to determining patient response which will be determined by recording the concurrent dose of norepinephrine and MAP every 10 minutes from initiation. If a positive response (e.g., norepinephrine dose reduction) is witnessed, the AT-II infusion will be titrated off after a maximum of 6 hours or when infusion is completed, whichever occurs first.

Eligibility Criteria

Age Range: 18 years to 99 years

Inclusion Criteria 1. Age ≥18; and 2. Requiring norepinephrine at a dose of 0.05-0.25 mcg/kg/min mcg/kg/minute despite adequate fluid resuscitation; and 3. Receiving intravenous antibiotics or clinician's intention to administer antibiotics at the time of enrollment; and 4. Can provide written informed consent (or legally authorized representative). Exclusion Criteria 1. Acute coronary syndrome; 2. Cardiogenic shock; 3. Patients with a history of mesenteric ischemia; 4. Patients with a history of having an aortic dissection or abdominal aortic aneurysm; 5. Patients with an expected lifespan of \<12 hours; 6. Patients with hemorrhagic shock (e.g., actively receiving transfusion of packed red blood cells); 7. Active administration of two vasoactive agents before enrollment; and 8. Pre-existing thromboembolic disease or inability to tolerate pharmacologic VTE prophylaxis.

Interventions

DRUG

Angiotensin II Infusion

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Conditions

Septic Shock

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States