Status:
RECRUITING
ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)
Lead Sponsor:
University of Maryland St. Joseph Medical Center
Collaborating Sponsors:
La Jolla Pharmaceutical Company
Conditions:
Vasodilatory Hypotension During or After Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this research is to evaluate the use of Angiotensin II in patients with low blood pressure post-surgery. Your information will be collected for 28 days post the procedure and initiation...
Eligibility Criteria
Inclusion
- Adult patients ≥ 18 years of age undergoing cardiac surgery requiring CPB
- Patients must have clinical features of vasodilation as determined by a MAP \< 65 mmHg that is non-transient in the opinion of the treating physician
- Patients must be adequately volume resuscitated in the opinion of the treating physician
- Systemic Vascular Resistance index (SVRi) \< 1970 dynes·sec/cm⁵/m² to support the clinical diagnosis of vasodilation; if no pulmonary artery catheter is in place, vasodilatory hypotension diagnosis according to the judgement of the critical care team
- Biventricular systolic function is at or greater than pre-cardiopulmonary bypass baseline as demonstrated by echocardiographic evaluation, or the patient is concomitantly treated with
Exclusion
- Bleeding as primary etiology of hypotension, as determined by \> 4 units RBC transfusion in 24 hours.
- Patients on ECMO
- Patients with active endocarditis
- Patients already on renal replacement therapy or creatinine of \> 4 mg/dl within 2 weeks of surgery
- Patients with contraindications to Angiotensin II including women who are pregnant or breastfeeding or have active coronary ischemia, mesenteric ischemia, limb ischemia, or high potassium (\> 5.5 meq/L) while receiving Angiotensin II
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06487585
Start Date
May 6 2025
End Date
February 1 2026
Last Update
December 22 2025
Active Locations (1)
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1
University of Maryland St. Joseph Medical Center
Towson, Maryland, United States, 21204