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

Last updated: October 14, 2024
Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Treatment

N/A

Clinical Study ID

NCT06539000
The RightScore
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age > 18 years

  • elective or urgent cardiac surgery at Campus BioMedico between January 2016 toDecember 2023

  • postoperative echocardiogram execution

  • ASA class I-IV

Exclusion

Exclusion Criteria:

  • age < 18 years

  • inotropic therapy at the time of surgery

Study Design

Total Participants: 2500
Study Start date:
October 01, 2024
Estimated Completion Date:
April 30, 2025

Study Description

Postoperative RVD will be defined as:

  • Echocardiographic parameters suggestive of RVD (at least 2 out of 3): TAPSE < 16 mmHg; right ventricular fractional area change (RVFAC) < 35%; right ventricular end systolic dilation > 3 cm (measured from the septum to the free wall).

AND

  • Need for inotropic and/or pulmonary vasodilator drug support and/or mechanical support.

Data will be collected retrospectively on: demographic characteristics; basic patient characteristics (weight, height, Body Mass Index -BMI, etc.); preoperative pharmacological therapy; preoperative comorbidities; abnormalities in blood tests; chest X-rays and ECGs; abnormalities in coronary angiography and carotid ultrasound; preoperative echocardiographic examination: TAPSE, Left Ventricular Ejection Fraction- LVEF, valvular pathologies, Pulmonary Artery Systolic Pressure- PAPs, pericardial effusion; type of surgical intervention; occlusion of the posterior interventricular coronary artery (acute or chronic); duration of the surgical procedure; duration of extracorporeal circulation; non-revascularized right coronary artery disease; blood product transfusions; postoperative pharmacological therapy (with particular regard to the use of inotropes/pulmonary vasodilators/vasopressors); postoperative echocardiographic examination: TAPSE; RVFAC; right ventricular dilation at end-systole; postoperative complications; Intensive Care Unit (ICU) length of stay and hospital length of stay.

Connect with a study center

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, Lazio 00128
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.