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Compares treatment options for Vasoplegic Syndrome of Cardiac Surgery
Official title Inotropic Effects of Vasopressin Versus Noradrenaline In Patients With Vasoplegic Syndrome After Cardiac Surgery
ClinicalTrials.gov ID: NCT06934798
What this study is testing
What is Vasopressin intravenous infusion?
Vasopressin intravenous infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for vasoplegic syndrome of cardiac surgery.
Also referred to as Arginine Vasopressin, ADH.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age over 18.
- Patients undergoing coronary artery bypass grafting, valve surgery or both, with a diagnosis of vasoplegic syndrome in the immediate postoperative...
You likely can't join if
- Pregnancy or breastfeeding.
- Aortic surgery.
- Surgeries to correct congenital heart disease.
- Heart transplants.
- Emergency surgery.
- Use of vasopressor therapy in the preoperative period.
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.