Shock
Conditions
Keywords
Shock, norepinephrine, vasopressin, cardiac surgery
Brief summary
Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The investigators hypothesized that the use of arginine vasopressin would be more effective on treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end point of mortality and severe morbidity.
Interventions
DRUGVasopressin
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement.
DRUGNorepinephrine
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* need vasopressor support
Exclusion criteria
* younger than 18 years; * surgery without cardiopulmonary bypass; * emergency procedure; * ascending and descending thoracic aortic procedures; * left ventricular aneurysm resection; enrollment in another study; * pregnancy; * neoplasm; * Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis; * severe hyponatremia (Na\<130mEq/L); * acute mesenteric ischemia; * acute myocardial infarction; * cardiogenic shock; and refusal to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of major morbidity according to Society of Thoracic Surgery | 30 days | The primary end point is major morbidity according to STS (30-days mortality, mechanical ventilation \> 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic effects | 28 days | the time to attainment of hemodynamic stability ; the changes in hemodynamic variables; and the use of dobutamine or other inotropic agents. |
| occurence of adverse events and safety | 28 days | Adverse events were categorized as arrhythmias, myocardial necrosis, skin necrosis, ischemia in limbs or distal extremities, or secondary infections |
| Time on mechanical ventilation | 30 days | Days on mechanical ventilation during 30-days after surgery. |
| Incidence of infecction | 30-days | Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery. |
| Length of ICU and Hospital stay | 90 days | Compare between groups the period of time (days) that patients were in ICU and in Hospital. |
Countries
Brazil
Contacts
Primary ContactLudhmila Hajjar, MD, PhD
Outcome results
None listed