Status:
RECRUITING
Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock
Lead Sponsor:
Kingman Regional Medical Center
Collaborating Sponsors:
La Jolla Pharmaceutical Company
Conditions:
Septic Shock
Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Norepinephrine is a catecholamine that is the first-line vasopressor for septic shock. The addition of non-catecholamine vasopressors, including vasopressin and angiotensin-II may be used in adults wi...
Detailed Description
Objectives: Primary Objective: 1\. To evaluate the efficacy of ang-II when used as the second vasopressor agent for septic shock Secondary Objectives: 1. To assess the duration of response to ang-...
Eligibility Criteria
Inclusion
- Patients admitted to the ICU within 12 hours of presentation to the emergency department for septic shock requiring 15-25 mcg/min of norepinephrine. Septic shock will be defined as having a known or presumed infection with two or more criteria of systemic inflammatory response syndrome, a mean arterial pressure \<65 mm Hg despite fluid resuscitation requiring vasopressor support, and a serum lactate \>2 mmol/L. Criteria of systemic inflammatory response syndrome include a temperature \>100.4°F or \<96.8°F; heart rate \>90/min; respiratory rate \>20/min and a white blood cell count \>12,000/mm3 or \<4,000/mm3.
Exclusion
- Age \<18 years
- Pregnancy or lactation
- Known allergic reactions to angiotensin-II or hydrocortisone sodium succinate
- Requiring \>25 mcg/min of norepinephrine or on any vasopressor other than norepinephrine at study enrollment
- Clinically significant bleeding precluding the use of chemical prophylaxis for venous thromboembolism
- Treatment with another investigational drug or other intervention during study timeframe
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06122987
Start Date
December 4 2023
End Date
January 1 2025
Last Update
May 23 2024
Active Locations (1)
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1
Kingman Regional Medical Center
Kingman, Arizona, United States, 86401