Clinical Trial

Inotropic Effects of Vasopressin Versus Noradrenaline In Patients With Vasoplegic Syndrome After Cardiac Surgery

Study acronym: INVASC
Recruiting Phase 4
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Record status
This record was last updated April 30, 2025 (before its estimated July 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a randomized, double-blind clinical trial designed to compare the inotropic effects of vasopressin versus norepinephrine in patients who develop vasoplegic syndrome in the immediate postoperative period following cardiac surgery. Vasoplegic syndrome is characterized by severe hypotension due to systemic vasodilation, despite adequate fluid resuscitation and preserved or elevated cardiac output. Vasopressors are essential in restoring hemodynamic stability in this context; however, their impact on myocardial performance remains uncertain. While norepinephrine is the standard first-line agent, vasopressin has shown potential benefits, including reduced catecholamine exposure and fewer adverse cardiovascular effects. This study aims to assess changes in cardiac output and other echocardiographic and hemodynamic parameters after administration of either vasopressin or norepinephrine. The findings are expected to contribute to optimizing vasopressor selection in vasoplegic patients after cardiac surgery and improving clinical outcomes.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-11; most recent amendment 2025-04-25.
Trial Details
NCT Number NCT06934798
Lead Sponsor University of Sao Paulo
Collaborators: Hospital Universitário Cassiano Antônio de Moraes/HUCAM, Hospital Santa Casa de Misericórdia de Vitória
Conditions Vasoplegic Syndrome of Cardiac Surgery
Enrollment 350 participants
Start Date 2024-04-01
Primary Completion 2025-07-30 (estimated)
Study Completion 2025-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-30