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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo

About this trial

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.

Eligibility criteria

Qualifiers

Age over 18.

Patients undergoing coronary artery bypass grafting, valve surgery or both, with a diagnosis of vasoplegic syndrome in the immediate postoperative period (<24 hours), defined as mean arterial pressure < 65 mmHg (measured using an invasive blood pressure catheter) and resistance to fluid replacement - at least 1000ml of crystalloids.

Disqualifiers

Pregnancy or breastfeeding.

Aortic surgery.

Surgeries to correct congenital heart disease.

Heart transplants.

Trial design

Treatments tested in this trial

  • Vasopressin intravenous infusion
  • Norepinephrine intravenous infusion

Treatment groups

350 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Sao Paulo

Lead sponsor

Hospital Universitário Cassiano Antônio de Moraes/HUCAM

Collaborator

Hospital Santa Casa de Misericórdia de Vitória

Collaborator