Septic Shock
Conditions
Keywords
Angiotensin II
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
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
Angiotensin II continuous infusion
Sponsors
Brett A Faine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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 informed consent (or legally authorized representative).
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of completing all clinical trial activities | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure response | 60 minutes after the intiation of angiotensin II infusion | Change in mean arterial pressure |
| Mean norepinephrine dose (during angiotensin II infusion) | 60 minutes after the intiation of angiotensin II infusion | Change in norepinephrine dose (mcg/kg/minute) after the initiation of angiotensin II infusion |
| Mean norepinephrine dose (post angiotensin II infusion) | 60 minutes after the completion of the angiotensin II infusion | Mean norepinephrine dose (mcg/kg/minute) after the completion of the angiotensin II infusion |
Countries
United States
Contacts
CONTACTBrett Faine, PharmD
Outcome results
None listed