Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Conditions
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Shock

Intervention / Treatment
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* Drug: Vasopressin
* Drug: Norepinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Norepinephrine group<br>Blinded norepinephrine | Drug: Norepinephrine<br>* Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement<br>|
| Active Comparator: Vasopressin Group<br>Blinded vasopressin | Drug: Vasopressin<br>* Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of major morbidity according to Society of Thoracic Surgery | The primary end point is major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic effects | the time to attainment of hemodynamic stability ; the changes in hemodynamic variables; and the use of dobutamine or other inotropic agents. | 28 days | 
| occurence of adverse events and safety | Adverse events were categorized as arrhythmias, myocardial necrosis, skin necrosis, ischemia in limbs or distal extremities, or secondary infections | 28 days | 
| Time on mechanical ventilation | Days on mechanical ventilation during 30-days after surgery. | 30 days | 
| Incidence of infecction | Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery. | 30-days | 
| Length of ICU and Hospital stay | Compare between groups the period of time (days) that patients were in ICU and in Hospital. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock, norepinephrine, vasopressin, cardiac surgery