ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)
Phase 4
Not yet recruiting
- Conditions
- Hypotension After Cardiac Surgery
- Interventions
- Registration Number
- NCT06487585
- Lead Sponsor
- University of Maryland St. Joseph Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
-
- Adult patients ≥ 18 years of age. 2. Patients must have clinical features of vasodilation, as determined by a MAP < 65 mmHg requiring any dose of vasopressors intra/post-operatively 3. Patients must be adequately volume resuscitated in the opinion of the treating physician.
Exclusion Criteria
-1. Patients with active bleeding as the primary reason for hypotension AND an anticipated need for transfusion of > 4 units packed red blood cells within the next 48 hours.
- History of atrial fibrillation 3. Patients already on renal replacement therapy or creatinine of > 4 mg/dl within 2 weeks of surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study Drug Arm - Angiotensin II arm Angiotensin II Angiotensin II
- Primary Outcome Measures
Name Time Method Incidence of postoperative acute kidney injury, atrial fibrillation 28 days The primary endpoint will be measured by comparing the incidence of new-onset atrial fibrillation or acute kidney injury
- Secondary Outcome Measures
Name Time Method Total IVF 28 days Any major STS complication 28 days Hours on Vasopressors 28 days ICU LOS 28 days Postoperative LOS 28 days 30-day mortality 30 days