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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiotensin II Infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiotensin II Infusion | Drug | Angiotensin II continuous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial pressure response | Change in mean arterial pressure | 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brett Faine, PharmD | Contact | +1 319 356 2577 | brett-faine@uiowa.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28528561 | Background | 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. | |
| 25286986 |
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Individual participant data that underlie the results reported in the manuscript, after deidentification (text, tables, figures, and appendices).
Immediately following publication. No end date.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| 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 | 60 minutes after the completion of the angiotensin II infusion |
| 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. |
| 37147690 | 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. |
| 26237037 | 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |