TerminatedPhase 4

Angiotensin II for Distributive Shock

Stopped: Enrollment Challenges

United States2 participantsStarted 2022-06-01

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Total Catecholamine Dose

Timeframe: 24 hours

Trial details

NCT IDNCT04904562

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01

Results submitted2026-03-24

View on ClinicalTrials.gov More Distributive Shock trials