Cardiopulmonary Bypass, Vasoplegia, Vasoplegic Shock
Conditions
Brief summary
The goal of this study is to conduct a prospective trial implementing a modified version of the Emory Protocol for administering ANG II to patients with post cardiac bypass vasoplegia. The main questions we aim to answer are: 1.) does administration of improve mortality, 2.) does the administration of Ang II using the modified protocol shorten the time needed to reach optimal MAP, 3.) does the administration of Ang II using the modified protocol shorten length of stay in the ICU and hospital? Researchers will compare outcomes from the interventional group to historical controls who did not receive Ang II using the modified protocol.
Detailed description
Giapreza is a synthetic human Ang II treatment which acts as a RAAS pathway regulator to rais MAP in adults. This will be a single center study comparing patients treated with a modified Emory protocol to historical controls who have not received Ang II. We will observe the effects of using a modified version of the Emory protocol, which includes lowering the dosages needed for norepinephrine and vasopressin. Additionally, clinicians will administer Ang II prior to starting methylene blue, a drug that poses more risk to patients than Ang II. Using this modified version of this protocol, patients who have post cardiopulmonary bypass vasoplegia who are already on vasopressin 0.04 units/min, norepinephrine 0.1 mcg/kg/min will have Ang II initiated at 10 to 20 ng/kg/min and titrated by 10 ng/kg/min every 5 minutes to a maximum dose of 80 ng/kg/min. If patients do not achieve their MAP goal of 65mmHg or greater within 3 hours, then they will have ANG II discontinued and will receive a dose of methylene blue at 2 mg/kg. If the patients do not achieve their MAP goal with methylene blue then they will receive a cyanokit.
Interventions
Patients who have post cardiopulmonary bypass vasoplegia who are already on vasopressin 0.04 units/min, norepinephrine 0.1 mcg/kg/min will have Ang II initiated at 10 to 20 ng/kg/min and titrated by 10 ng/kg/min every 5 minutes to a maximum dose of 80 ng/kg/min.
Sponsors
Methodist Healthcare System of San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 94 Years
Healthy volunteers
No
Inclusion criteria
* In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 or over 4. Exhibiting vasoplegia or vasoplegic shock following surgeries involving cardiopulmonary bypass 5. MAP below results below 65mmHg
Exclusion criteria
* An individual who meets any of the following criteria will be excluded from participation in this study: 1. Current use of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) 2. Presence of treatment with high-dose glucocorticoids 3. Pregnancy or lactation 4. Known allergic reactions to components of the Giapreza, \<specify components/allergens\> 5. Febrile illness within \<specify time frame\> 6. Treatment with another investigational drug or other intervention within \<specify time frame\> 7. Current smoker or tobacco use within \<specify timeframe\> 8. Currently receiving VA ECMO for cardiogenic shock 9. Experiencing uncontrolled hemorrhage 10. Presenting with burns over 20% or more of body, acute coronary syndrome, bronchial spasms, liver failure, mesenteric ischemia, abdominal aortic aneurysm, or an absolute neutrophil count less than 1000 cubic millimeters
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 365 days | in-hospital or post-hospital mortality within 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure | Hours 3, 6, 9, 12, 24 and 48, | Changes in Mean Arterial Pressure |
| Length of Stay | 1 year | ICU |
Outcome results
None listed