ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery) (NCT06487585) | Clinical Trial Compass
RecruitingPhase 4
ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)
United States100 participantsStarted 2025-05-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Incidence of postoperative acute kidney injury, atrial fibrillation
Timeframe: 28 days
Trial details
NCT IDNCT06487585
SponsorUniversity of Maryland St. Joseph Medical Center