ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)

University of Maryland St. Joseph Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Vasodilatory Hypotension During or After Cardiac Surgery

Treatments: Drug: Angiotensin II

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06487585

00109542

Details and patient eligibility

About

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 of the study drug to assess for safety events and complications.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Study Drug Arm - Angiotensin II arm

Other group

Description:

Angiotensin II

Treatment:

Drug: Angiotensin II