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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01505231


Contacts
Contact: Ludhmila Hajjar, MD, PhD 55-11-93194401 ludhmila@usp.br

Locations
Brazil
Instituto do Coração Recruiting
São Paulo, Brazil, 05403-000
Contact: Ludhmila Hajjar, MD, PhD    55-11-93194401    ludhmila@usp.br   
Sponsors and Collaborators
University of Sao Paulo
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ludhmila Abrahão Hajjar, principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01505231     History of Changes
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:
Shock
norepinephrine
vasopressin
cardiac surgery

Additional relevant MeSH terms:
Shock
Pathologic Processes
Norepinephrine
Vasopressins
Arginine Vasopressin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents