Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT06934798

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

Led by University of Sao Paulo · Updated on 2025-04-30

350

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

Sponsors

U

University of Sao Paulo

Lead Sponsor

H

Hospital Universitário Cassiano Antônio de Moraes/HUCAM

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Patients undergoing coronary artery bypass grafting, valve surgery, or both
  • Diagnosis of vasoplegic syndrome within 24 hours after surgery, defined as mean arterial pressure below 65 mmHg despite at least 1000 mL of fluid replacement
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Aortic surgery
  • Surgery to correct congenital heart disease
  • Heart transplant
  • Emergency surgery
  • Use of vasopressor therapy before surgery
  • Presence of ventricular assist device other than intra-aortic balloon after surgery
  • Severe low sodium levels after surgery (less than 130 mEq/L)
  • Postoperative acute coronary syndrome
  • Mesenteric ischemia after surgery
  • History of Raynaud's disease
  • History of cancer

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Instituto do Coração HCFMUSP

São Paulo, Brazil, 05403-000

Actively Recruiting

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Research Team

J

José León

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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