Angiotensin II for Septic Shock
(DARK-Sepsis Trial)
Trial Summary
What is the purpose of this trial?
This trial will be a randomized controlled single-center pilot trial comparing the use of angiotensin II versus standard-of-care (SOC) vasopressor therapy in adult patients with persistent vasodilatory shock despite moderate-dose norepinephrine, with a primary outcome of the ability of novel biomarkers (renin and DPP3) to predict blood pressure response to angiotensin II. Given our angiotensin II will be compared to SOC, this will be an unblinded study.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Angiotensin II (Giapreza) for treating septic shock?
Angiotensin II has been shown to increase blood pressure within 3 hours in patients with septic shock, and it can reduce the need for other blood pressure-raising drugs. It has been approved for use in septic shock due to its ability to improve blood flow and potentially change outcomes for patients.12345
Is Angiotensin II (Giapreza) generally safe for humans?
How is the drug Angiotensin II (Giapreza) different from other treatments for septic shock?
Angiotensin II (Giapreza) is unique because it works by increasing blood pressure quickly, within 3 hours, and can reduce the need for other blood pressure-raising drugs (catecholamines) in septic shock. It is a newer option approved for use when other treatments are not effective, offering a different mechanism by targeting the body's renin-angiotensin-aldosterone system.123411
Research Team
Joao P Teixeira, MD
Principal Investigator
University of New Mexico
Nathan D Nielsen, MD MSc
Principal Investigator
University of New Mexico
Eligibility Criteria
Adults over 18 with persistent vasodilatory shock despite certain treatments, who have specific catheters in place and are not fluid responsive. They must be able to consent or have a representative do so, and not fall under exclusion criteria like acute stroke, severe liver failure, high-dose steroid use, extensive burns, very low neutrophils count, active bleeding with low hemoglobin levels or conditions contraindicating blood sampling.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Angiotensin II or standard-of-care vasopressor therapy for septic shock
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes such as ICU and hospital mortality, and adverse events
Treatment Details
Interventions
- Angiotensin II
Angiotensin II is already approved in United States for the following indications:
- Septic shock
- Vasodilatory shock
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of New Mexico
Lead Sponsor
La Jolla Pharmaceutical Company
Industry Sponsor