Inotropic Effects of Vasopressin Versus Noradrenaline In Patients With Vasoplegic Syndrome After Cardiac Surgery
Recruiting now · Phase 4
Conditions studied: Vasoplegic Syndrome of Cardiac Surgery
In brief
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.
Key facts
- Study ID
- NCT06934798
- Run by
- University of Sao Paulo
- People needed
- 350
- Starts
- 2024-04-01
- Expected to finish
- 2025-07-30
- Last updated by the study team
- 2025-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Pregnancy or breastfeeding.
- Aortic surgery.
- Surgeries to correct congenital heart disease.
- Heart transplants.
- Emergency surgery.
- Use of vasopressor therapy in the preoperative period.
- Presence of a ventricular assist device other than an intra-aortic balloon in the postoperative period.
- Severe hyponatremia in the postoperative period (serum sodium less than 130mEq/l).
- Postoperative acute coronary syndrome.
- Mesenteric ischemia in the postoperative period.
- History of Raynaud's disease.
- History of neoplasia.
Where it is running
- Instituto do Coração HCFMUSP — São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
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