| 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 |
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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 |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research,Sector 12, Chandigarh- 160012 |
|
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Primary Sponsor
|
| Name |
Post Graduate Institiute of Medical Education and Research |
| Address |
Sector 12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical and Research |
Approved |
|
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Regulatory Clearance Status from DCGI
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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, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
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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 |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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 |
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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" |
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Phase of Trial
|
N/A |
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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