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

Primary Purpose

Shock

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Vasopressin
Norepinephrine
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock focused on measuring Shock, norepinephrine, vasopressin, cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto do CoraçãoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Norepinephrine group

Vasopressin Group

Arm Description

Blinded norepinephrine

Blinded vasopressin

Outcomes

Primary Outcome Measures

Composite endpoint of major morbidity according to Society of Thoracic Surgery
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
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
Adverse events were categorized as arrhythmias, myocardial necrosis, skin necrosis, ischemia in limbs or distal extremities, or secondary infections
Time on mechanical ventilation
Days on mechanical ventilation during 30-days after surgery.
Incidence of infecction
Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery.
Length of ICU and Hospital stay
Compare between groups the period of time (days) that patients were in ICU and in Hospital.

Full Information

First Posted
January 2, 2012
Last Updated
February 11, 2013
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01505231
Brief Title
Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery
Acronym
VaNCS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock
Keywords
Shock, norepinephrine, vasopressin, cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Norepinephrine group
Arm Type
Active Comparator
Arm Description
Blinded norepinephrine
Arm Title
Vasopressin Group
Arm Type
Active Comparator
Arm Description
Blinded vasopressin
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Intervention Description
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
Primary Outcome Measure Information:
Title
Composite endpoint of major morbidity according to Society of Thoracic Surgery
Description
The primary end point is major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hemodynamic effects
Description
the time to attainment of hemodynamic stability ; the changes in hemodynamic variables; and the use of dobutamine or other inotropic agents.
Time Frame
28 days
Title
occurence of adverse events and safety
Description
Adverse events were categorized as arrhythmias, myocardial necrosis, skin necrosis, ischemia in limbs or distal extremities, or secondary infections
Time Frame
28 days
Title
Time on mechanical ventilation
Description
Days on mechanical ventilation during 30-days after surgery.
Time Frame
30 days
Title
Incidence of infecction
Description
Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery.
Time Frame
30-days
Title
Length of ICU and Hospital stay
Description
Compare between groups the period of time (days) that patients were in ICU and in Hospital.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ludhmila Hajjar, MD, PhD
Phone
55-11-93194401
Email
ludhmila@usp.br
Facility Information:
Facility Name
Instituto do Coração
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludhmila Hajjar, MD, PhD
Phone
55-11-93194401
Email
ludhmila@usp.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
25947955
Citation
O'Callaghan DJ, Gordon AC. What's new in vasopressin? Intensive Care Med. 2015 Dec;41(12):2177-9. doi: 10.1007/s00134-015-3849-3. Epub 2015 May 7. No abstract available.
Results Reference
derived

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Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery

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