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Not Yet Recruiting NCT07671365

Angiotensin II for Post Cardiac Surgery Vasoplegia (ANGII_V)

Conditions: Vasoplegic Shock, Cardiopulmonary Bypass, Vasoplegia

Sex: All
Ages: 18 Years – 94 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 329
Sponsor: Methodist Healthcare System of San Antonio

Summary

The goal of this study is to conduct a prospective trial implementing a modified version of the Emory Protocol for administering ANG II to patients with post cardiac bypass vasoplegia. The main questions we aim to answer are: 1.) does administration of improve mortality, 2.) does the administration of Ang II using the modified protocol shorten the time needed to reach optimal MAP, 3.) does the administration of Ang II using the modified protocol shorten length of stay in the ICU and hospital? Researchers will compare outcomes from the interventional group to historical controls who did not receive Ang II using the modified protocol.

Eligibility Criteria

Inclusion Criteria: * In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 or over 4. Exhibiting vasoplegia or vasoplegic shock following surgeries involving cardiopulmonary bypass 5. MAP below results below 65mmHg Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: 1. Current use of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) 2. Presence of treatment with high-dose glucocorticoids 3. Pregnancy or lactation 4. Known allergic reactions to components of the Giapreza, \ 5. Febrile illness within \ 6. Treatment with another investigational drug or other intervention within \ 7. Current smoker or tobacco use within \ 8. Currently receiving VA ECMO for cardiogenic shock 9. Experiencing uncontrolled hemorrhage 10. Presenting with burns over 20% or more of body, acute coronary syndrome, bronchial spasms, liver failure, mesenteric ischemia, abdominal aortic aneurysm, or an absolute neutrophil count less than 1000 cubic millimeters

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07671365). StuddyBuddy aggregates publicly available trial information.