RECRUITING

Angiotensin II for Distributive Shock

Description

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
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Related Conditions:

Distributive Shock

Study Overview

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Study Details

Study overview

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)

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

Angiotensin II for Distributive Shock

Condition
Distributive Shock
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients (18 years of age or older)
  • 2. 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.
  • 1. Patients without distributive shock,
  • 2. Women who are pregnant or breastfeeding.
  • 3. Patients who do not receive the study drug as a first line agent for distributive shock
  • 4. Allergy to angiotensin II, angiotensin II or another vasopressor being used at the time of presentation to the operating room
  • 5. Preexisting distributive shock
  • 6. Preexisting thromboembolic disease
  • 7. Patients who are unwilling to provide consent

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Choy Lewis, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

2024-12-31