Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Instituto do Coração HCFMUSP
São Paulo, Brazil, 05403-000
Actively Recruiting
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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