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Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery (VaNCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Ludhmila Abrahão Hajjar, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Shock Drug: Vasopressin Drug: Norepinephrine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2012
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: Norepinephrine group
Blinded norepinephrine
Drug: Norepinephrine
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
Drug: Vasopressin
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement.

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Time on mechanical ventilation [ Time Frame: 30 days ]
    Days on mechanical ventilation during 30-days after surgery.

  4. Incidence of infecction [ Time Frame: 30-days ]
    Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery.

  5. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01505231

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Contact: Ludhmila Hajjar, MD, PhD 55-11-93194401

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Instituto do Coração Recruiting
São Paulo, Brazil, 05403-000
Contact: Ludhmila Hajjar, MD, PhD    55-11-93194401   
Sponsors and Collaborators
University of Sao Paulo
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ludhmila Abrahão Hajjar, principal investigator, University of Sao Paulo Identifier: NCT01505231    
Other Study ID Numbers: 0352/08
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013
Keywords provided by Ludhmila Abrahão Hajjar, University of Sao Paulo:
cardiac surgery
Additional relevant MeSH terms:
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Pathologic Processes
Arginine Vasopressin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents