ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland St. Joseph Medical Center
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Angiotensin II
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Maryland St. Joseph Medical Center
Lead sponsor
La Jolla Pharmaceutical Company
Collaborator
Source ClinicalTrials.gov