Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06693726 | NOT YET RECRUITING | Septic Shock

Early Angiotensin II in the Emergency Department
Sponsor:

University of Iowa

Information provided by (Responsible Party):

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 (within 3 hours of norepinephrine initiation) of angiotensin II for treatment of septic shock in the ED

Condition or disease

Septic Shock

Intervention/treatment

Angiotensin II Infusion

Phase

PHASE4

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 Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : ANGIOtensin II for Septic Shock in the Emergency Department: ANGIO-ED Study
Actual Study Start Date : 2025-01-31
Estimated Primary Completion Date : 2026-01-31
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
    • Early Angiotensin II in the Emergency Department

    Location Details

    NCT06693726

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, Iowa

    University of Iowa Hospitals and Clinics

    Iowa City, Iowa, United States, 52242