Inotropic Effects of Vasopressin Versus Noradrenaline In Patients With Vasoplegic Syndrome After Cardiac Surgery
Launched by UNIVERSITY OF SAO PAULO · Apr 11, 2025
Trial Information
Current as of November 08, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of two medications, vasopressin and norepinephrine, in patients who develop a condition called vasoplegic syndrome after heart surgery. Vasoplegic syndrome can cause very low blood pressure even when patients receive enough fluids and their heart is functioning well. The goal of this study is to find out which medication is better at improving heart function and blood pressure in these patients. While norepinephrine is commonly used, vasopressin may have benefits that could lead to fewer side effects.
To participate in this trial, patients need to be over 18 years old and must have undergone certain heart surgeries, like coronary artery bypass or valve surgery, and have been diagnosed with vasoplegic syndrome shortly after surgery. Participants can expect to receive either vasopressin or norepinephrine and will be monitored closely for changes in heart performance and blood pressure. It's important to know that there are some exclusions, such as being pregnant, having certain heart conditions, or having undergone specific types of surgeries. This study aims to improve treatment options for patients experiencing this serious condition after heart surgery.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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.
About University Of Sao Paulo
The University of São Paulo (USP) is a prestigious public research university located in Brazil, renowned for its commitment to advancing knowledge and innovation in various fields, including medicine and health sciences. As a clinical trial sponsor, USP leverages its extensive academic resources, interdisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking research aimed at improving patient outcomes and addressing critical health challenges. The university's strong emphasis on ethical standards and regulatory compliance ensures that all clinical trials are conducted with the highest integrity, fostering collaboration among researchers, healthcare professionals, and the broader community to enhance scientific discovery and translate findings into practical applications.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
São Paulo, Brazil
Patients applied
Trial Officials
Ludhmila A Hajjar, Full Professor
Principal Investigator
University of Sao Paulo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported