Early Angiotensin II in the Emergency Department

Phase 4

Recruiting

• Conditions: Septic Shock
• Interventions: Drug: Angiotensin II Infusion

• Registration Number: NCT06693726
• Lead Sponsor: Brett A Faine

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Study Start: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-01-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Angiotensin II Infusion	Angiotensin II Infusion	-

Primary Outcome Measures

Name	Time	Method
Feasibility of completing all clinical trial activities	From enrollment to the end of treatment up to 6 hours after the angiotensin II infusion is initiated	Percentage of patients who provide informed consent and receive angiotensin II infusion in the emergency department

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure response	60 minutes after the intiation of angiotensin II infusion	Change in mean arterial pressure
Mean norepinephrine dose (during angiotensin II infusion)	60 minutes after the intiation of angiotensin II infusion	Change in norepinephrine dose (mcg/kg/minute) after the initiation of angiotensin II infusion
Mean norepinephrine dose (post angiotensin II infusion)	60 minutes after the completion of the angiotensin II infusion	Mean norepinephrine dose (mcg/kg/minute) after the completion of the angiotensin II infusion

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States