Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery (VaNCS)
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|ClinicalTrials.gov Identifier: NCT01505231|
Recruitment Status : Unknown
Verified February 2013 by Ludhmila Abrahão Hajjar, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : January 6, 2012
Last Update Posted : February 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Shock||Drug: Vasopressin Drug: Norepinephrine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||May 2013|
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.
- Composite endpoint of major morbidity according to Society of Thoracic Surgery [ Time Frame: 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)
- Hemodynamic effects [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 days ]Days on mechanical ventilation during 30-days after surgery.
- Incidence of infecction [ Time Frame: 30-days ]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 ]Compare between groups the period of time (days) that patients were in ICU and in Hospital.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|