Vasodilatory Hypotension During or After Cardiac Surgery
Conditions
Keywords
Vasodilation, Hypotension, Cardiopulmonary Bypass, Cardiac Surgery
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.
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.
Sponsors
La Jolla Pharmaceutical Company
University of Maryland St. Joseph Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Total IVF | 28 days |
| ICU LOS | 28 days |
| Postoperative LOS | 28 days |
| Hours on Vasopressors | 28 days |
| 30-day mortality | 30 days |
| Cost | 28 days |
| Any major STS complication | 28 days |
Countries
United States
Contacts
Primary ContactAja Janyavula
Backup ContactSam Rudow
Outcome results
None listed