Angiotensin II for Low Blood Pressure During Surgery

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TT
Overseen ByThomas Templeton, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Wake Forest University Health Sciences
Must be taking: Ace inhibitors, Arbs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Angiotensin II, a type of medication, can prevent low blood pressure in patients with high blood pressure undergoing surgery. Low blood pressure during surgery can harm vital organs, especially in those taking medications like ACE inhibitors or ARBs. The trial includes different groups based on the type of blood pressure medication participants use. Individuals with high blood pressure who have been on medications such as ACE inhibitors, ARBs, or similar drugs for over two months and are scheduled for surgery may be suitable for this trial. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it includes patients already on certain blood pressure medications, you might be able to continue them. Please confirm with the trial coordinators.

What is the safety track record for Angiotensin II?

Research has shown that Angiotensin II is generally safe for use during surgery. Studies have found it to be well-tolerated by patients undergoing various surgeries, including those on the kidney, liver, heart, and lungs. Although some patients have experienced irregular heartbeats during surgery, medical teams carefully monitor these occurrences.

The FDA has already approved Angiotensin II for treating certain types of low blood pressure, indicating its safety when used properly. In small studies and reports, patients treated with Angiotensin II have not shown major side effects, suggesting it could be a safe option for managing low blood pressure during surgery. However, discussing any concerns with a healthcare provider before joining a trial is important.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Angiotensin II for treating low blood pressure during surgery because it works differently from standard treatments like vasopressors. While traditional options often stimulate adrenergic receptors to raise blood pressure, Angiotensin II directly constricts blood vessels by mimicking a natural hormone in the body responsible for regulating blood pressure. This unique mechanism can offer a more targeted approach, potentially reducing the risk of side effects associated with other medications. Plus, its rapid onset can be particularly beneficial during surgery when quick blood pressure control is crucial.

What is the effectiveness track record for Angiotensin II in treating low blood pressure during surgery?

Research has shown that Angiotensin II effectively treats low blood pressure during surgery. Studies have found that it can quickly raise blood pressure to safe levels. In this trial, participants will be divided into groups based on their current antihypertensive medications, such as ACE inhibitors, ARBs, or other classes, and will receive Angiotensin II. Previous findings suggest that Angiotensin II effectively manages low blood pressure, especially in patients taking medications like ACE inhibitors or ARBs. This treatment supports blood pressure without causing severe side effects. Overall, it has proven to be a reliable option for managing blood pressure issues during surgery.13467

Who Is on the Research Team?

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Rohesh Fernando, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure who are undergoing general anesthesia and have been treated with blood pressure medications, including ACE inhibitors or ARBs, for over two months. It's not suitable for individuals with asthma, severe obesity (BMI > 40), pregnant women, those with a history of serious heart or lung conditions, stroke, deep vein thrombosis or difficult airways.

Inclusion Criteria

I will be put to sleep for surgery.
I have been treated for high blood pressure with medication for over 2 months.

Exclusion Criteria

I have chronic obstructive pulmonary disease.
You have a hard time breathing.
I have had a heart attack or have cardiac stents.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) administration of Angiotensin II to manage hypotension during general anesthesia

up to 1 hour
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Angiotensin II
Trial Overview The study is testing the effectiveness of intravenous Angiotensin II as a treatment for low blood pressure that occurs during general anesthesia in patients who already have high blood pressure and are on certain medications.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Participants on ARBsExperimental Treatment1 Intervention
Group II: Participants on ACE inhibitorsExperimental Treatment1 Intervention
Group III: Other Classes of Antihypertensive AgentsExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Giapreza for:

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Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

Angiotensin II (Giapreza) was successfully used to treat vasodilation caused by a tricyclic overdose, improving hemodynamic parameters in the patient.
This novel application of angiotensin II may allow for lower doses of other vasopressors, potentially enhancing patient outcomes in cases of vasodilatory shock.
A Patient With Tricyclic Antidepressant Overdose With Catecholamine-Resistant Hypotension Rescued With Angiotensin II: A Case Report.Ferdowsali, J., Ferdowsali, K.[2021]
A single oral dose of captopril significantly reduced blood pressure in 26 patients with renovascular disease, indicating its effectiveness as an acute angiotensin-converting enzyme (ACE) inhibitor.
The blood pressure response to captopril was predictive of postoperative outcomes, with a strong correlation between preoperative captopril-induced blood pressure changes and postoperative blood pressure levels, suggesting it could be a useful tool for anticipating surgical results.
Acute response to captopril as a predictive test for surgery in renovascular hypertension.Salvetti, A., Arzilli, F., Nuccorini, A., et al.[2018]
Acute blockade of B2 receptors using icatibant significantly prevents blood pressure drops in mice treated with angiotensin-converting enzyme inhibitors during hemorrhagic shock, indicating a potential protective mechanism.
The study shows that B2 receptor blockade can rapidly and effectively mitigate the harmful hemodynamic effects associated with angiotensin-converting enzyme inhibitor treatment, which could be beneficial for patients undergoing emergency anesthesia or resuscitation.
Acute Bradykinin Receptor Blockade During Hemorrhagic Shock in Mice Prevents the Worsening Hypotensive Effect of Angiotensin-Converting Enzyme Inhibitor.Charbonneau, H., Buléon, M., Minville, V., et al.[2018]

Citations

Angiotensin Receptor Blockade Does Not Decrease ...Hypotension during the perioperative KT period was defined according to our institutional protocol as an SBP < 120 mmHg. Our kidney transplant ...
Angiotensin II treatment of hypotension in noncardiac surgeryAng II was titrated every minute until SBP was within 5% of baseline. The infusion rate was not increased by more than 15 ng kg−1 min−1 at a ...
Study Details | Angiotensin II in the Perioperative ...Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...
Angiotensin II as a Vasopressor for Perioperative ...Safety outcomes include incidence of thromboembolism within 48 h of the end of surgery and severe hypertension.
Protocol Compliance Guiding Angiotensin II Use in Post...The Angiotensin II for the Treatment of High-Output Shock 3 (ATHOS-3) study demonstrated that administration of Ang II supports low blood pressure and reduces ...
Angiotensin II in the Perioperative Management of ...The safety endpoints that will be captured will include: incidence of intraoperative arrhythmias for those who receive study drug ...
Effect of continuing angiotensin-converting enzyme ...Intraoperative hypotension during non-cardiac surgery has been linked to elevated risks of adverse outcomes and mortality [9,10]. Specifically, myocardial ...
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