Shock Clinical Trial
— VaNCSVasoplegic 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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto do Coração | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | Time on mechanical ventilation | Days on mechanical ventilation during 30-days after surgery. | 30 days | Yes |
Secondary | Incidence of infecction | Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery. | 30-days | Yes |
Secondary | Length of ICU and Hospital stay | Compare between groups the period of time (days) that patients were in ICU and in Hospital. | 90 days | Yes |
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