Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery

Phase 3

• Conditions: Shock
• Interventions: Drug: Vasopressin; Drug: Norepinephrine

• Registration Number: NCT01505231
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-12
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vasopressin Group	Vasopressin	Blinded vasopressin
Norepinephrine group	Norepinephrine	Blinded norepinephrine

Primary Outcome Measures

Name	Time	Method
Composite endpoint of major morbidity according to Society of Thoracic Surgery	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

Name	Time	Method
Hemodynamic effects	28 days	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	28 days	Adverse events were categorized as arrhythmias, myocardial necrosis, skin necrosis, ischemia in limbs or distal extremities, or secondary infections
Time on mechanical ventilation	30 days	Days on mechanical ventilation during 30-days after surgery.
Incidence of infecction	30-days	Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery.
Length of ICU and Hospital stay	90 days	Compare between groups the period of time (days) that patients were in ICU and in Hospital.

Trial Locations

Locations (1)

Instituto do Coração; 🇧🇷 São Paulo, Brazil