Angiotensin II for Distributive Shock
NCT04904562 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2026-04-13
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 transplant or left ventricular assist device placement will be enrolled. Participants will be randomized to Angiotensin II (Giapreza) vs. placebo plus standard of care, as a first line agent for vasoplegia. Two groups of patients will be enrolled:
* Group A: Heart Transplant (10 control, 10 treatment)
* Group B: LVAD implant (10 control, 10 treatment)
Conditions
- Distributive Shock
Interventions
- DRUG
-
Angiotensin II
Angiotensin II started at 5 ng/kg/min and titrated in 5-10 ng/kg/min increments every 5 minutes up to 80ng/kg/min to achieve target arterial pressure (MAP)
- DRUG
-
Placebo
Sponsors & Collaborators
-
La Jolla Pharmaceutical Company
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Choy Lewis, MD · Northwestern University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-01
- Primary Completion
- 2024-05-01
- Completion
- 2024-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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