ClinicalTrials.gg
Sign In
RecruitingNCT06693726ANGIO-EDUpdated Sep 2, 2026

Early Angiotensin II in the Emergency Department

A Phase 4 interventional study of Angiotensin II Infusion in Septic Shock, sponsored by Brett A Faine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Brett A Faine · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Septic Shock

Browse trials for

Keywords

  • Angiotensin II
03

In context

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 20 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Brett A Faine is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (or legally authorized representative).

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Angiotensin II Infusion

    Drug: Angiotensin II Infusion

Interventions

06

What researchers measure

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

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

Secondary outcomes

  1. Mean arterial pressure response

    Change in mean arterial pressure

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

  2. Mean norepinephrine dose (during angiotensin II infusion)

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

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

  3. Mean norepinephrine dose (post angiotensin II infusion)

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 28528561 ↗
  • 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. PubMed 25286986 ↗
  • 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. PubMed 37147690 ↗
  • 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. PubMed 26237037 ↗

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in the manuscript, after deidentification (text, tables, figures, and appendices).

Supporting information: Study protocol, Clinical study report

Time frame: Immediately following publication. No end date.

Access criteria: Researchers who provide a methodologically sound proposal.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06693726
Lead sponsor
Brett A Faine
Responsible party
Brett A Faine (Clinical Associate Professor, University of Iowa) — Sponsor-investigator
First posted
Nov 18, 2024
Start date
Apr 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Brett Faine, PharmD
Contact
brett-faine@uiowa.edu
+1 319 356 2577

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Angiotensin II

Other studies in this condition

Shock, Septic →

Other studies from this sponsor

Brett A Faine

Start the discussion