RECRUITING

Angiotensin II for Distributive Shock

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2022-06-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04904562

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients (18 years of age or older)
  2. 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. 1. Patients without distributive shock,
  2. 2. Women who are pregnant or breastfeeding.
  3. 3. Patients who do not receive the study drug as a first line agent for distributive shock
  4. 4. Allergy to angiotensin II, angiotensin II or another vasopressor being used at the time of presentation to the operating room
  5. 5. Preexisting distributive shock
  6. 6. Preexisting thromboembolic disease
  7. 7. Patients who are unwilling to provide consent

Contacts and Locations

Study Contact

Choy Lewis, MD
CONTACT
312-926-5589
Choy.Lewis@nm.org

Principal Investigator

Choy Lewis, MD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Choy Lewis, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-06-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Vasoplegia

Additional Relevant MeSH Terms

  • Distributive Shock