CompletedNot Applicable

Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery

Italy1,000 participantsStarted 2024-10-01

Plain-language summary

Right ventricular dysfunction (RVD) is common following cardiac surgery, and it is characterised by impaired right ventricular function that can lead to decreased cardiac output and hemodynamic instability. RVD is consistently associated with poor outcomes. The mechanisms behind RVD post-surgery involve changes in preload, after load, and RV contraction. Factors linked to higher incidence of postoperative RVD include decreased tricuspid annular plane excursion (TAPSE), elevated preoperative pulmonary artery pressure, lung diseases, duration of extracorporeal circulation, and left valve surgery. While predictive scores for RVD exist for left ventricular assist device (LVAD) patients, no such models are available for other cardiac surgeries. Identifying specific predictors could lead to models that identify high-risk patients, allowing for tailored monitoring and treatment strategies. The primary aim of this study is to create a preoperative risk score for predicting the development of right ventricular dysfunction following adult cardiac surgery through a retrospective analysis on patients who underwent heart surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age \> 18 years * elective or urgent cardiac surgery at Campus BioMedico between January 2016 to December 2023 * postoperative echocardiogram execution * ASA class I-IV Exclusion Criteria: * age \< 18 years * inotropic therapy at the time of surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Creation of a preoperative risk score for predicting the development of right ventricular dysfunction after adult cardiac surgery.

Timeframe: September 2024 - December 2025

Trial details

NCT IDNCT06539000

SponsorFondazione Policlinico Universitario Campus Bio-Medico

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Right Ventricular Dysfunction trials