Early Angiotensin II in the Emergency Department (ANGIO-ED)

Brett A Faine

Status and phase: Enrolling; Phase 4

Conditions: Septic Shock

Treatments: Drug: Angiotensin II Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06693726

202406277

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Angiotensin II Infusion

Experimental group

Treatment:

Drug: Angiotensin II Infusion