Status:
RECRUITING
Inotropic Effects of Vasopressin Versus Noradrenaline In Patients With Vasoplegic Syndrome After Cardiac Surgery
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Hospital Universitário Cassiano Antônio de Moraes/HUCAM
Hospital Santa Casa de Misericórdia de Vitória
Conditions:
Vasoplegic Syndrome of Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 postoperat...
Detailed Description
This prospective, randomized, double-blind clinical trial investigates the inotropic effects of vasopressin versus norepinephrine in patients who develop vasoplegic syndrome (VS) in the immediate post...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2025
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06934798
Start Date
April 1 2024
End Date
July 30 2025
Last Update
April 30 2025
Active Locations (1)
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1
Instituto do Coração HCFMUSP
São Paulo, Brazil, 05403-000