NCT06934798RecruitingPhase 4
Inotropic Effects of Vasopressin Versus Noradrenaline In Patients With Vasoplegic Syndrome After Cardiac Surgery
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 11 Apr 2025
- Start date
- 1 Apr 2024
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- University of Sao Paulo
- NCT number
- NCT06934798
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 350
- From 1 Apr 2024 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Aortic surgery.
- Emergency surgery.
- Use of vasopressor therapy in the preoperative period.
Other illness
- Surgeries to correct congenital heart disease.
- Heart transplants.
- Postoperative acute coronary syndrome.
- History of Raynaud's disease.
- History of neoplasia.
Lab values
- Severe hyponatremia in the postoperative period (serum sodium less than 130mEq/l).
Other
- Pregnancy or breastfeeding.
- Presence of a ventricular assist device other than an intra-aortic balloon in the postoperative period.
- Mesenteric ischemia in the postoperative period.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Coração - HCFMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.