Status:
UNKNOWN
Angiotensin II for Distributive Shock
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
La Jolla Pharmaceutical Company
Conditions:
Distributive Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a single-center, randomized, double-blind, placebo-controlled pilot study. A total of 40 patients who develop distributive shock, intra-operatively or post-operatively within 48 hours of heart...
Detailed Description
Patients undergoing implantation of a durable left ventricular assist devices (LVAD) or a heart transplantation are at increased risk for cardiac vasoplegia. Vasoplegia, during or following cardiac su...
Eligibility Criteria
Inclusion
- Patients (18 years of age or older)
- Onset of distributive shock within 48 hours after heart transplantation or VAD placement. Distributive shock defined as MAP less than 55mmHg on CPB, MAP less than 70mmHg before or after CPB, or systemic vascular resistance (SVR) less than 800 dynes/cm/sec5 with cardiac index (CI) greater than 2.0L/min/m2 and clinically determined euvolemia.
Exclusion
- Patients without distributive shock,
- Women who are pregnant or breastfeeding.
- Patients who do not receive the study drug as a first line agent for distributive shock
- Allergy to angiotensin II, angiotensin II or another vasopressor being used at the time of presentation to the operating room
- Preexisting distributive shock
- Preexisting thromboembolic disease
- Patients who are unwilling to provide consent
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04904562
Start Date
June 1 2022
End Date
December 31 2024
Last Update
November 13 2023
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611