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

University of Sao Paulo

Status and phase: Unknown; Phase 3

Conditions: Shock

Treatments: Drug: Norepinephrine; Drug: Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT01505231

0352/08

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

Norepinephrine group

Active Comparator group

Description:

Blinded norepinephrine

Treatment:

Drug: Norepinephrine

Vasopressin Group

Active Comparator group

Description:

Blinded vasopressin

Treatment:

Drug: Vasopressin