Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery (VaNCS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Composite endpoint of major morbidity according to Society of Thoracic Surgery [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]The primary end point is major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure)
- Hemodynamic effects [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]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 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Adverse events were categorized as arrhythmias, myocardial necrosis, skin necrosis, ischemia in limbs or distal extremities, or secondary infections
- Time on mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Days on mechanical ventilation during 30-days after surgery.
- Incidence of infecction [ Time Frame: 30-days ] [ Designated as safety issue: Yes ]Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery.
- Length of ICU and Hospital stay [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Compare between groups the period of time (days) that patients were in ICU and in Hospital.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Norepinephrine group
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
Active Comparator: Vasopressin Group
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505231
|Contact: Ludhmila Hajjar, MD, PhDfirstname.lastname@example.org|
|Instituto do Coração||Recruiting|
|São Paulo, Brazil, 05403-000|
|Contact: Ludhmila Hajjar, MD, PhD 55-11-93194401 email@example.com|