Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery
NCT Number: NCT06539000
Acronym: The RightScore
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Right Ventricular Dysfunction
Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-04-30
Locations: Fondazione Policlinico Universitario Campus Bio-Medico, Roma, Lazio, 00128, Italy

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.

Primary Outcome Measures: Creation of a preoperative risk score for predicting the development of right ventricular dysfunction after adult cardiac surgery., Preoperative patient characteristics (demographic features, BMI, preoperative conditions, etc.) and surgical factors (type of procedure, duration of cardiopulmonary bypass, duration of surgery, etc.) will be correlated with the development of RVD in the early postoperative period. Scores will be assigned to factors showing significant correlation. The sum of these scores will yield the total score and thus the risk level.

Unabbreviated score title: The RightScore

Minimum/maximum values: Depending on the number of risk factors associated with right ventricular dysfunction.

Higher scores indicate worse outcomes., September 2024 - April 2025
Secondary Outcome Measures: Retrospective validation of the created score (The RightScore) on adult cardiac surgery patients operated at Policlinico Fondazione Campus Bio-Medico between January 2016 and December 2023., The RightScore will be calculated using retrospectively analyzed data for every adult patient operated on at Policlinico Fondazione Campus Bio-Medico between January 2016 and December 2023. Preoperative and intraoperative data will be used to predict postoperative right ventricular dysfunction. This prediction will be correlated with the actual development of postoperative right ventricular dysfunction to retrospectively validate the score created.

Unabbreviated score title: The RightScore

Minimum/maximum values: Depending on the number of risk factors associated with right ventricular dysfunction.

Higher scores indicate worse outcomes., September 2024 - April 2025|Correlation between postoperative RVD and postoperative outcomes., Correlation with mortality, stroke, multi-organ dysfunction, re-intubation, cardiac arrest, increased length of stay in the ICU, increased hospital stay., September 2024 - April 2025|Sub-analysis of the risk score., Sub-analysis of the risk score for the subtype of surgery performed by the patient.

Unabbreviated score title: The RightScore

Minimum/maximum values: Depending on the number of risk factors associated with right ventricular dysfunction.

Higher scores indicate worse outcomes., September 2024 - April 2025