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CTRI Number  CTRI/2025/11/097774 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Correlating congestion status and right heart functions in patients undergoing heart valve surgery 
Scientific Title of Study   CORRELATION OF INDIVIDUAL COMPONENTS AND OF OVERALL VExUS SCORE WITH ECHOCARDIOGRAPHIC PARAMETERS OF RIGHT HEART DIMENSIONS AND FUNCTIONS IN ADULTS UNDERGOING CARDIAC VALVULAR SURGERY : A PROSPECTIVE OBSERVATIONAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vendra S R 
Designation  Senior Resident  
Affiliation  PGIMER 
Address  Department of Cardiac Anaesthesia and Intensive care, Advanced Cardiac Centre, 4th level, PGIMER.
Department of Cardiac Anaesthesia and Intensive care, Advanced Cardiac Centre, 4th level, PGIMER.
Chandigarh
CHANDIGARH
160012
India 
Phone  09840756002  
Fax    
Email  vendrasr97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Indranil Biswas 
Designation  Associate professor  
Affiliation  PGIMER 
Address  Department of Cardiac Anaesthesia and Intensive care, Advanced Cardiac Centre, 4th level, PGIMER.
Department of Cardiac Anaesthesia and Intensive care, Advanced Cardiac Centre, 4th level, PGIMER.
Chandigarh
CHANDIGARH
16001
India 
Phone  7710449858  
Fax    
Email  hreesheekombartta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Indranil Biswas 
Designation  Associate professor  
Affiliation  PGIMER 
Address  Department of Cardiac Anaesthesia and Intensive care, Advanced Cardiac Centre, 4th level, PGIMER.
Department of Cardiac Anaesthesia and Intensive care, Advanced Cardiac Centre, 4th level, PGIMER.
Chandigarh
CHANDIGARH
16001
India 
Phone  7710449858  
Fax    
Email  hreesheekombartta@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research,Sector 12, Chandigarh- 160012 
 
Primary Sponsor  
Name  Post Graduate Institiute of Medical Education and Research  
Address  Sector 12, Chandigarh  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vendra S R  OT COMPLEX, ADVANCED CARDIAC CENTRE  Department of Cardiac Anaesthesia and Intensive care, Advanced Cardiac Centre, 4th level, PGIMER.
Chandigarh
CHANDIGARH 
09840756002

vendrasr97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post Graduate Institute of Medical and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I05||Rheumatic mitral valve diseases, (2) ICD-10 Condition: I06||Rheumatic aortic valve diseases, (3) ICD-10 Condition: I08||Multiple valve diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  undergoing cardiac valvular surgery 
 
ExclusionCriteria 
Details  1.Declined consent
2.Surgery of congenital heart disease
3.Poor transthoracic window
4.Pericardial disease
5.Existing tricuspid ring/prosthesis
6.Patient on renal replacement therapy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the correlation between individual components of the Venous Excess Ultrasound (VExUS) score, as well as the composite VExUS score, with echocardiographic parameters reflecting right heart dimensions and function.  Prior to anaesthesia induction in operating room 
 
Secondary Outcome  
Outcome  TimePoints 
1. To identify the VExUS score component that demonstrates the strongest correlation with echocardiographic indicators of right heart size and function.  Prior to anaesthesia induction in operating room 
To assess the incremental predictive value of the preoperative VExUS score in estimating short-term perioperative morbidity and mortality following cardiac valvular surgery.


 
upto 28 days following surgery 
 
Target Sample Size   Total Sample Size="157"
Sample Size from India="157" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The primary purpose of this research protocol is to evaluate the relationship between the Venous Excess Ultrasound VExUS score a comprehensive point of care ultrasound method for assessing systemic venous congestion and echocardiographic measures of right heart structure and function in adult patients undergoing cardiac valvular surgery This prospective observational study arises from the knowledge that traditional means of evaluating congestion such as physical examination and isolated inferior vena cava IVC assessment are often subjective inconsistent and influenced by technical and physiologic variables As right ventricular RV function and venous congestion have broad implications for outcomes in cardiac surgery the study aims to provide a more objective and reliable correlation using an integrated ultrasound approach with the VExUS score

Rationale and Background

Venous congestion is a key determinant of morbidity following cardiac surgery frequently driven by RV dysfunction and assessment by standard right heart catheterization is invasive and not always feasible The VExUS score combining IVC hepatic vein portal vein and renal vein Doppler ultrasonography offers a realtime noninvasive alternative to gauge venous congestion with greater accuracy Understanding the precise relationship between VExUS and echocardiographic surrogates of RV function such as TAPSE tricuspid annular plane systolic excursion RV fractional area change FAC and RV systolic pressure RVSP can improve patient risk stratification fluid management and outcome prediction in perioperative care

The protocol specifically seeks to

Quantify the correlation between the grades and severity of each VExUS component hepatic portal and renal vein Doppler patterns and overall VExUS score against established echocardiographic parameters reflecting right heart dimensions like RV basal diameter RA area and function TAPSE RV FAC RV systolic pressure Identify which single VExUS component most strongly mirrors the severity and nature of right heart impairment Determine whether preoperative VExUS measurements offer incremental predictive value for perioperative morbidity including acute kidney injury liver dysfunction mechanical ventilation need ICU stay and mortality beyond established surgical risk scores such as EuroSCORE II and STS score

Study Hypothesis

The study hypothesizes that noninvasive assessment of systemic venous congestion using VExUS will demonstrate a strong positive correlation with echocardiographic parameters reflecting right ventricular function particularly with indices such as TAPSE and RV FAC It further posits that higher VExUS scores and severity grades will be associated with worse RV function on echocardiography and that this relationship will help guide management decisions and outcome prediction in the perioperative cardiac surgical population

By systematically exploring these relationships the study aims to validate the utility of VExUS scoring in the cardiac anesthesia critical care domain and guide best practices for fluid and congestion management of vulnerable patients undergoing complex valvular surgeries

 
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