Early Angiotensin II in the Emergency Department

NCT06693726 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 202406277
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Septic Shock

Keywords

Angiotensin II

Outcome Measures

Primary Outcomes (1)

• Feasibility of completing all clinical trial activities

  Percentage of patients who provide informed consent and receive angiotensin II infusion in the emergency department

  From enrollment to the end of treatment up to 6 hours after the angiotensin II infusion is initiated

Secondary Outcomes (3)

• Mean arterial pressure response

  60 minutes after the intiation of angiotensin II infusion

• Mean norepinephrine dose (during angiotensin II infusion)

  60 minutes after the intiation of angiotensin II infusion

• Mean norepinephrine dose (post angiotensin II infusion)

  60 minutes after the completion of the angiotensin II infusion

Study Arms (1)

Angiotensin II Infusion

EXPERIMENTAL

Drug: Angiotensin II Infusion

Interventions

Angiotensin II Infusion DRUG

Angiotensin II continuous infusion

Angiotensin II Infusion

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brett A Faine: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (4)

• Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.

  PMID: 28528561 BACKGROUND

• Chawla LS, Busse L, Brasha-Mitchell E, Davison D, Honiq J, Alotaibi Z, Seneff MG. Intravenous angiotensin II for the treatment of high-output shock (ATHOS trial): a pilot study. Crit Care. 2014 Oct 6;18(5):534. doi: 10.1186/s13054-014-0534-9.

  PMID: 25286986 BACKGROUND

• Wieruszewski PM, Bellomo R, Busse LW, Ham KR, Zarbock A, Khanna AK, Deane AM, Ostermann M, Wunderink RG, Boldt DW, Kroll S, Greenfeld CR, Hodges T, Chow JH; Angiotensin II for the Treatment of High-Output Shock 3 (ATHOS-3) Investigators. Initiating angiotensin II at lower vasopressor doses in vasodilatory shock: an exploratory post-hoc analysis of the ATHOS-3 clinical trial. Crit Care. 2023 May 5;27(1):175. doi: 10.1186/s13054-023-04446-1.

  PMID: 37147690 BACKGROUND

• Avni T, Lador A, Lev S, Leibovici L, Paul M, Grossman A. Vasopressors for the Treatment of Septic Shock: Systematic Review and Meta-Analysis. PLoS One. 2015 Aug 3;10(8):e0129305. doi: 10.1371/journal.pone.0129305. eCollection 2015.

  PMID: 26237037 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Brett Faine, PharmD

CONTACT

+1 319 356 2577; brett-faine@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)