Angiotensin II as first-line blood pressure support after cardiac bypass surgery

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

This test will try angiotensin II to raise blood pressure in adults who develop lasting low blood pressure during or after heart surgery with cardiopulmonary bypass.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Maryland St. Joseph Medical Center (other)
• Locations: 1 site (Towson, Maryland)
• Trial ID: NCT06487585 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional study gives angiotensin II to adult patients who develop vasodilatory hypotension during or after cardiac surgery requiring cardiopulmonary bypass. Eligible patients have sustained MAP <65 mmHg judged to be due to vasodilation and are considered adequately volume resuscitated; a low systemic vascular resistance index may be used when available to support the diagnosis. Participants receive angiotensin II as the vasopressor intervention and are monitored for hemodynamic response, safety events, and complications. Clinical data and safety outcomes are collected for 28 days after drug initiation.

Who should consider this trial

Good fit: Adults (≥18) undergoing cardiac surgery with cardiopulmonary bypass who develop sustained vasodilatory hypotension (MAP <65 mmHg), are judged adequately volume resuscitated, and meet the listed inclusion/exclusion criteria are ideal candidates.

Not a fit: Patients whose hypotension is primarily due to bleeding, those on ECMO, with active endocarditis, or already receiving renal replacement therapy are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this could provide an alternative to traditional vasopressors and help restore blood pressure more reliably in post-bypass vasodilatory shock.

How similar studies have performed: Angiotensin II has been shown to raise MAP in distributive shock in prior trials (for example ATHOS-3), but using it as first-line therapy specifically after cardiac surgery is less well established.

Eligibility criteria

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

Where this trial is running

Towson, Maryland

• University of Maryland St. Joseph Medical Center — Towson, Maryland, United States (RECRUITING)

Study contacts

• Study coordinator: Aja Janyavula

Conditions: Vasodilatory Hypotension During or After Cardiac Surgery, Vasodilation, Hypotension, Cardiopulmonary Bypass, Cardiac Surgery