Using Angiotensin II to treat distributive shock after heart surgery
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
This study is testing if Angiotensin II can help patients who have distributive shock after heart surgery by reducing the need for other medications to raise blood pressure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04904562 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of Angiotensin II as a first-line treatment for patients experiencing distributive shock following heart transplantation or left ventricular assist device (LVAD) placement. A total of 40 patients will be randomly assigned to receive either Angiotensin II or a placebo, alongside standard care, within 48 hours of surgery. The study aims to determine if Angiotensin II can reduce the total dose of catecholamine vasopressors needed in the first 24 hours after the onset of vasoplegia. Secondary outcomes will assess the duration of hypotension and other related clinical parameters.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who develop distributive shock within 48 hours after heart transplantation or LVAD placement.
Not a fit: Patients without distributive shock or those with preexisting conditions that contraindicate the use of Angiotensin II will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from distributive shock after heart surgery.
How similar studies have performed: Previous studies have shown that Angiotensin II can effectively reduce catecholamine use in similar patient populations, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: 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
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Choy Lewis, MD — Northwestern University
- Study coordinator: Choy Lewis, MD
- Email: Choy.Lewis@nm.org
- Phone: 312-926-5589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.