Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539000
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The RIGHT-SCORE Study a Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
The RightScore
Brief 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
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
Detailed 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 andor pulmonary vasodilator drug support andor 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 inotropespulmonary vasodilatorsvasopressors 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
- 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 andor pulmonary vasodilator drug support andor 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 inotropespulmonary vasodilatorsvasopressors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None