Comparing vasopressin and norepinephrine for treating low blood pressure after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, double-blind investigation comparing the effects of vasopressin versus norepinephrine in patients who develop vasoplegic syndrome shortly after cardiac surgery. Vasoplegic syndrome leads to severe low blood pressure despite adequate fluid resuscitation, and this study aims to determine which vasopressor is more effective in improving cardiac output and hemodynamic stability. Eligible patients will receive either vasopressin or norepinephrine, with their responses monitored through various echocardiographic and hemodynamic parameters. The findings could help refine treatment protocols for managing this serious postoperative complication.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto do Coração HCFMUSP
  São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Ludhmila A Hajjar, Full Professor — University of Sao Paulo
• Study coordinator: José León
• Email: aro@incor.usp.br
• Phone: +55 (11) 2661-5795

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Monitoring small- and large-vessel blood flow during heart surgery in patients at risk of vasoplegic syndrome

  We will test whether adding earlobe and palm skin sensors plus clinical and blood measurements during and for 48 hours after heart surgery helps understand and predict vasoplegic syndrome in patients at higher risk.

  Recruiting European Georges Pompidou Hospital · Paris · NCT07059715

• HPA (stress hormone) function in adults who develop vasoplegia after cardiac surgery

  This project will test whether the body's stress-hormone system (the HPA axis and cortisol response) is altered in adults who develop vasoplegic syndrome after heart surgery.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT06371976

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.