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RecruitingPhase 4NCT06487585

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

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

Sponsor

University of Maryland St. Joseph Medical Center

Enrollment

100 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

Vasodilatory Hypotension During or After Cardiac Surgery

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

DRUGAngiotensin II

Angiotensin II: Starting dose of 2.5 ng/kg/min administered IV; may dose escalate up to 80 ng/kg/min in order to achieve a MAP of 65 mmHg or higher in the first 3 hours. After 3 hours, may escalate dose up to 40 ng/kg/min in order to achieve a MAP of 65 mmHg. Dose titration in increments of 10 ng/kg/min every 2 minutes.

Locations(1)

University of Maryland St. Joseph Medical Center

Towson, Maryland, United States

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NCT06487585