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

This study is currently recruiting participants.
Verified February 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Ludhmila Abrahão Hajjar, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01505231
First received: January 2, 2012
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Shock
 Drug: Vasopressin
Drug: Norepinephrine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ludhmila Abrahão Hajjar, principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01505231     History of Changes
Other Study ID Numbers: 0352/08
Study First Received: January 2, 2012
Last Updated: February 11, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Shock
norepinephrine
vasopressin
cardiac surgery

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

ClinicalTrials.gov processed this record on May 19, 2013