Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery

Shock Clinical Trial

— VaNCS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01505231
• Other study ID #: 0352/08
• Status: Recruiting
• Phase: Phase 3
• First received: January 2, 2012
• Last updated: February 11, 2013
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2013
• Source: University of Sao Paulo
• Contact: Ludhmila Hajjar, MD, PhD
• Phone: 55-11-93194401
• Email: ludhmila[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Shock

Intervention

Drug:
• Vasopressin
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement.
• Norepinephrine
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement

Locations

Country	Name	City	State
Brazil	Instituto do Coração	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	30 days	Yes
Secondary	Hemodynamic effects	the time to attainment of hemodynamic stability ; the changes in hemodynamic variables; and the use of dobutamine or other inotropic agents.	28 days	Yes
Secondary	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	28 days	Yes
Secondary	Time on mechanical ventilation	Days on mechanical ventilation during 30-days after surgery.	30 days	Yes
Secondary	Incidence of infecction	Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery.	30-days	Yes
Secondary	Length of ICU and Hospital stay	Compare between groups the period of time (days) that patients were in ICU and in Hospital.	90 days	Yes