Septic ShockPhase 4ANGIO-EDNCT06693726
Early Angiotensin II in the Emergency Department
A Phase 4 study testing Angiotensin II Infusion in people with Septic Shock, run by Brett A Faine at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Angiotensin II Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Brett Faine, 3193108067, brett-faine@uiowa.edu
About this study
Official title: ANGIOtensin II for Septic Shock in the Emergency Department: ANGIO-ED Study
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.
- Conditions
- Septic Shock
- Being tested
- Angiotensin II Infusion
- Keywords
- Angiotensin II
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin II InfusionDrug
Angiotensin II continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Angiotensin II Infusion | Experimental | Not described Receives: Drug: Angiotensin II Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of completing all clinical trial activities
Percentage of patients who provide informed consent and receive angiotensin II infusion in the emergency department
Measured: 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
Change in mean arterial pressure
Measured: 60 minutes after the intiation of angiotensin II infusion
Mean norepinephrine dose (during angiotensin II infusion)
Change in norepinephrine dose (mcg/kg/minute) after the initiation of angiotensin II infusion
Measured: 60 minutes after the intiation of angiotensin II infusion
Mean norepinephrine dose (post angiotensin II infusion)
Mean norepinephrine dose (mcg/kg/minute) after the completion of the angiotensin II infusion
Measured: 60 minutes after the completion of the angiotensin II infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brett A Faine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brett A Faine, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693726
- Sponsor's protocol ID
- 202406277
- Acronym
- ANGIO-ED
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the manuscript, after deidentification (text, tables, figures, and appendices).
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 28528561Chawla 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 25286986Wieruszewski 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 37147690Avni 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANGIOtensin II for Septic Shock in the Emergency Department: ANGIO-ED Study
- ClinicalTrials.gov ID
- NCT06693726
- Acronym / sponsor ID
- ANGIO-ED / 202406277
- Conditions
- Septic Shock
- Keywords
- Angiotensin II
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brett A FaineUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angiotensin II Infusion | Experimental | Drug: Angiotensin II Infusion |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin II InfusionAngiotensin II continuous infusion | Drug | Angiotensin II Infusion |
Primary outcome
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
3 secondary outcomes
Mean arterial pressure response
Time frame: 60 minutes after the intiation of angiotensin II infusion
Mean norepinephrine dose (during angiotensin II infusion)
Time frame: 60 minutes after the intiation of angiotensin II infusion
Mean norepinephrine dose (post angiotensin II infusion)
Time frame: 60 minutes after the completion of the angiotensin II infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 28528561Khanna 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.
- Background: PubMed 25286986Chawla 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.
- Background: PubMed 37147690Wieruszewski 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.
- Background: PubMed 26237037Avni 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the manuscript, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiotensin II Infusion in people with Septic Shock, run by Brett A Faine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Faine, PharmD (+1 319 356 2577, brett-faine@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06693726, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.