Angiotensin II for Distributive Shock
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called Angiotensin II to determine its effectiveness for patients experiencing distributive shock (a severe drop in blood pressure) shortly after heart transplants or left ventricular assist device (LVAD) placements. The study compares the effects of Angiotensin II with a placebo (an inactive treatment), alongside the usual care these patients receive. Participants will be divided into two groups based on whether they had a heart transplant or LVAD implant. The trial seeks individuals who have experienced distributive shock within 48 hours of these surgeries and are not currently using Angiotensin II as another treatment. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how Angiotensin II can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that the study drug must be used as a first line agent for distributive shock, which might affect your current treatment plan.
What is the safety track record for Angiotensin II (Giapreza)?
Research has shown that Angiotensin II, also known as Giapreza, has been studied for its safety in treating distributive shock. In a study with 321 adults, researchers found that the treatment was generally well-tolerated, with most patients not experiencing serious side effects. The study demonstrated that Angiotensin II can help increase blood pressure, which is crucial for patients in shock. While some side effects can occur, they are usually manageable. The treatment is already approved for use in septic shock, indicating a strong safety record. Overall, Angiotensin II appears to be a safe option, making it a promising choice for those considering joining a trial.12345
Why are researchers enthusiastic about this study treatment?
Angiotensin II is unique because it targets the renin-angiotensin system to stabilize blood pressure in cases of distributive shock, which is often challenging to manage with standard treatments like norepinephrine or vasopressin. Unlike these common vasopressors, Angiotensin II directly acts on blood vessels to constrict them and increase blood pressure. Researchers are excited about this treatment because it offers a new mechanism of action, providing a potential alternative for patients who do not respond well to other vasopressors. Additionally, its rapid administration and adjustable dosing could make it a flexible and effective option in critical care settings.
What evidence suggests that Angiotensin II might be an effective treatment for distributive shock?
Research has shown that Angiotensin II, which participants in this trial may receive, can effectively raise blood pressure in patients with vasodilatory shock, a condition where blood vessels are too relaxed. One study found it helped patients reach their target blood pressure when other treatments were ineffective. Another study demonstrated that Angiotensin II allowed patients to reduce their use of other blood pressure medications. This suggests it can be an important option to stabilize patients with this type of shock. Although it did not lower the death rate, controlling blood pressure remains crucial for these patients. Overall, Angiotensin II has shown promising results in managing this serious condition.26789
Who Is on the Research Team?
Choy Lewis, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Angiotensin II or placebo as a first-line vasopressor for vasoplegia
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of acute kidney injury, stroke, and other secondary outcomes
Extended Follow-up
Participants are monitored for long-term outcomes such as ICU and hospital length of stay, 30-day mortality, and allograft rejection
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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
Intravenous (IV) infusion (saline)
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?
Northwestern University
Lead Sponsor
La Jolla Pharmaceutical Company
Industry Sponsor
Citations
Efficacy and Trial Design | GIAPREZA® (angiotensin II)
GIAPREZA was studied in ATHOS-3, an international, randomized, double-blind, placebo-controlled study of 321 patients with distributive shock.
ANGIOTENSIN II IN THE TREATMENT OF DISTRIBUTIVE ...
While ATII did not reduce mortality among distributive shock patients, it allowed for significant adjunctive vasopressor reduction at 3 h without an increase ...
3.
janesthanalgcritcare.biomedcentral.com
janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-024-00186-yThe use of angiotensin II for the management of distributive ...
Clinical studies evaluating the use of ATII in critically ill patients with distributive shock reported promising results, with improvements ...
Angiotensin II for the Treatment of Vasodilatory Shock
Angiotensin II effectively increased blood pressure in patients with vasodilatory shock that did not respond to high doses of conventional vasopressors.
5.
jmsma.scholasticahq.com
jmsma.scholasticahq.com/article/131791-single-center-real-world-observational-analysis-of-angiotensin-ii-salvage-therapy-for-refractory-shockSingle-Center, Real-World Observational Analysis of ...
Fourteen (67%) presented with distributive shock. At angiotensin-II initiation, 76% of patients were on at least three other vasopressors at a ...
Safety & Adverse Events | GIAPREZA® (angiotensin II)
The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in a randomized, double-blind, placebo-controlled study, ATHOS-3.
The use of angiotensin II for the management of distributive ...
... shock [13]. In addition, ATII therapy appears to have a favorable safety profile, with minimal adverse effects reported in clinical trials.
209360Orig1s000 - accessdata.fda.gov
The results of ATHOS-3 constitute substantial evidence of the effectiveness of angiotensin II for increasing blood pressure in adults with ...
Angiotensin II Brings More Questions Than Answers - PMC
The recent approval of angiotensin II (ATII) gives clinicians a new tool for treating patients with septic shock. The drug is highly effective at improving ...
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