Early Angiotensin II in the Emergency Department
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Angiotensin II Infusion.
- Who it may be relevant to
- Registry conditions: Septic Shock. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ANGIOtensin II for Septic Shock in the Emergency Department: ANGIO-ED Study
Overview
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.
Interventions
- Drug Angiotensin II Infusion
Angiotensin II continuous infusion
Primary outcome measures
- 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]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Iowa Hospitals and Clinics — Iowa City
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 Sho PMID 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. PMID 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; PMID 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. PMID 26237037
Identifiers
NCT: NCT06693726 · 202406277