Angiotensin II for Distributive Shock

Overseen By Choy Lewis, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Must not be taking: Vasopressors

Disqualifiers: Pregnancy, Thromboembolic disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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)

Research Team

Choy Lewis, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults who develop distributive shock within 48 hours after a heart transplant or left ventricular assist device (LVAD) placement. They must have specific blood pressure and resistance criteria met, with normal cardiac output. Pregnant or breastfeeding women, those unwilling to consent, patients already on vasopressors before surgery, or with preexisting thromboembolic disease or distributive shock are excluded.

Inclusion Criteria

I experienced shock soon after my heart transplant or VAD placement.

Exclusion Criteria

I have a condition where my blood flow is not normal, leading to low blood pressure.

I am allergic to certain blood pressure medications.

I have not used the study drug as the first treatment for my shock condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Angiotensin II or placebo as a first-line vasopressor for vasoplegia

24 hours

Continuous monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of acute kidney injury, stroke, and other secondary outcomes

48 hours

Extended Follow-up

Participants are monitored for long-term outcomes such as ICU and hospital length of stay, 30-day mortality, and allograft rejection

1 year

Treatment Details

Interventions

• Angiotensin II
• Placebo

Trial Overview The study tests Angiotensin II (Giapreza) against a placebo in managing low blood pressure due to distributive shock post-heart surgery. It's a small-scale test involving 40 patients split into two groups: one for heart transplants and another for LVAD implants, each further divided equally between the drug and placebo.

Participant Groups

Group I: Treatment Active Control 1 Intervention

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

Group II: Control Placebo Group 1 Intervention

Intravenous (IV) infusion (saline)

Angiotensin II is already approved in United States for the following indications:

Approved in United States as Giapreza for:

• Septic shock
• Vasodilatory shock

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

La Jolla Pharmaceutical Company

Industry Sponsor

Trials

24

Recruited

2,700+