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NCT Number: NCT06693726

Early Angiotensin II in the Emergency Department

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

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Brett Faine

CONTACT

[email protected]

3193108067

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18; and
  • Requiring norepinephrine at a dose of 0.05-0.25 mcg/kg/min mcg/kg/minute despite adequate fluid resuscitation; and
  • Receiving intravenous antibiotics or clinician's intention to administer antibiotics at the time of enrollment; and
  • Can provide written informed consent (or legally authorized representative).

Exclusion criteria

  • Acute coronary syndrome;
  • Cardiogenic shock;
  • Patients with a history of mesenteric ischemia;
  • Patients with a history of having an aortic dissection or abdominal aortic aneurysm;
  • Patients with an expected lifespan of <12 hours;
  • Patients with hemorrhagic shock (e.g., actively receiving transfusion of packed red blood cells);
  • Active administration of two vasoactive agents before enrollment; and
  • Pre-existing thromboembolic disease or inability to tolerate pharmacologic VTE prophylaxis.

Treatment and study plan

Angiotensin II Infusion

Drug

Angiotensin II continuous infusion

Primary outcomes

  1. Feasibility of completing all clinical trial activities

    Time frame: 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 outcomes

  1. Mean arterial pressure response

    Time frame: 60 minutes after the intiation of angiotensin II infusion

    Change in mean arterial pressure

  2. Mean norepinephrine dose (during angiotensin II infusion)

    Time frame: 60 minutes after the intiation of angiotensin II infusion

    Change in norepinephrine dose (mcg/kg/minute) after the initiation of angiotensin II infusion

  3. Mean norepinephrine dose (post angiotensin II infusion)

    Time frame: 60 minutes after the completion of the angiotensin II infusion

    Mean norepinephrine dose (mcg/kg/minute) after the completion of the angiotensin II infusion

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Faine, PharmD

CONTACT

[email protected]

+1 319 356 2577

Sponsors and collaborators

Lead sponsor

Brett A Faine

Other

Registry information

Official study title

ANGIOtensin II for Septic Shock in the Emergency Department: ANGIO-ED Study

Acronym: ANGIO-ED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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