Angiotensin II for Distributive Shock

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Distributive Shock

In brief

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)

Key facts

Study ID: NCT04904562
Run by: Northwestern University
People needed: 2
Starts: 2022-06-01
Expected to finish: 2024-07-01
Last updated by the study team: 2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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