Angiotensin II for Distributive Shock

Launched by NORTHWESTERN UNIVERSITY · May 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Angiotensin II (also known as Giapreza) in patients experiencing a condition called distributive shock after heart surgery. Distributive shock can happen when the blood vessels are too relaxed, leading to low blood pressure that can be dangerous. The trial will involve 40 patients who are either undergoing a heart transplant or receiving a left ventricular assist device (LVAD). Participants will be divided into two groups, with some receiving Angiotensin II and others receiving a placebo (which looks like the medication but has no active ingredients), along with standard treatment.

To be eligible for this trial, patients need to be 18 years or older and must develop distributive shock within 48 hours after their surgery. Certain individuals, such as those who are pregnant, have allergies to the medication, or have other serious health conditions, will not be able to participate. If you join the trial, you will receive either the study drug or a placebo, and your healthcare team will monitor your health closely to see how well the treatment is working. This research aims to improve care for patients experiencing this serious condition after heart surgery.

Gender

ALL

Eligibility 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