Angiotensin II as a First-line Vasopressor for Distributive Shock During or After Heart Transplantation or Durable Left Ventricular Assist Device Implantation: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Choy Lewis, MD
Choy.Lewis@nm.org
312-926-5589
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: Treatment
Angiotensin II administered as an intravenous (IV) infusion will be increased every 5 minutes by 5-10ng/kg/min increments up to 80ng/kg/min
Placebo_comparator: Control
Intravenous (IV) infusion (saline)
Related Therapeutic Areas
Sponsors
Collaborators: La Jolla Pharmaceutical Company
Leads: Northwestern University

This content was sourced from clinicaltrials.gov