FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077675 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Correlation between the VExUS score and right atrial pressure of heart in pediatric patients with in born heart disease planned of any heart intervention : observational study. 
Scientific Title of Study   Correlation between the VExUS score and right atrial pressure in pediatric patients with congenital heart disease: a prospective observational study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SANDEEP KUMAR 
Designation  Post graduate student 
Affiliation  ARMED FORCE MEDICAL COLLEGE 
Address  Dept of anaesthesia Armed force medical college Fatima nagar Pune

Pune
MAHARASHTRA
411040
India 
Phone  8277633892  
Fax    
Email  sandykj99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ALOK KUMAR 
Designation  Professor and senior advisor 
Affiliation  Armed Force Medical College 
Address  Dept of anaesthesia Army institute of cardiothoracic sciences Golibar maidan Pune

Pune
MAHARASHTRA
411040
India 
Phone  8146044104  
Fax    
Email  mipayal07@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR ALOK KUMAR 
Designation  Professor and senior advisor 
Affiliation  Armed Force Medical College 
Address  Dept of anaesthesia Army institute of cardiothoracic sciences Golibar maidan Pune

Pune
MAHARASHTRA
411040
India 
Phone  8146044104  
Fax    
Email  mipayal07@gmail.com  
 
Source of Monetary or Material Support  
Armed Force Medical College , Fatima Nagar 411040 .Pune ,Maharashtra , INDIA 
 
Primary Sponsor  
Name  Dr Sandeep Kumar 
Address  Department of Anaesthesiology , AFMC ,Fatima Nagar ,Pune , Maharashtra ,, 411010, India. 
Type of Sponsor  Other [SELF] 
 
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 Alok Kumar  Armed Force Medical College  Armed Force Medical College , Fatima Nagar, 411040
Pune
MAHARASHTRA 		 8146044104

mipayal07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q249||Congenital malformation of heart,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1.Pediatric patients diagnosed with congenital heart disease below 14 years of age
2.Patients scheduled for cardiac Cath intervention or any cardiac intervention
3.Patients or their legal guardians must provide informed consent for participation in the study. 
 
ExclusionCriteria 
Details  Patients aged more than 14 years.
1. Patients with coagulopathy, pre-existing sepsis, on inotropes or mechanically ventilated.
2.Patients with severe hemodynamic instability or severe ventricular dysfunction that may affect the correlation between the VExUS score and right atrial pressure.
3.Patients who have undergone previous cardiac surgeries to focus on the impact of the current cardiac intervention.
4.Patients with primary pulmonary hypertension or severe pulmonary disease, as these conditions may independently influence right atrial pressure.
5.Patients with advanced chronic kidney disease, as impaired renal function can affect fluid balance and hemodynamics  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the correlation between the VExUS score and right atrial pressure in pediatric patients with congenital heart disease   At 1 minute after insertion of central venous catheter.
At 24 hrs after the surgery/intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate the predictive validity of the VExUS score in estimating right atrial pressure in the pediatric patients with congenital heart disease.
2.To explore whether there is an association between the VExUS score & postoperative clinical outcomes, such as the occurrence of complications, length of hospital stay, or the need for additional interventions in pediatric cardiac patients 		 1.pre operative grading
2.Post operative outcomes at
24 hrs 48hrs  
 
Target Sample Size   Total Sample Size="37"
Sample Size from India="37" 
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)   16/12/2024 
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="6"
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  

1.Venous congestion is an under-recognized contributor to mortality in critically ill cardiac patients.

 Unfortunately, venous congestion is difficult to measure, and right heart catheterization (RHC) has been considered the most readily available mean for measuring venous filling pressure.

2.Recently, a novel “Venous Excess Ultrasound (VExUS)”score was developed to noninvasively quantify venous congestion using inferior vena cava (IVC) diameter and Doppler flow through the hepatic, portal, and renal veins. A preliminary retrospective study of post-cardiac surgery patients in adult population showed promising results, including a high positive-likelihood ratio of high VExUS grade for acute kidney injury.

3.Our study aims to investigate and establish the relationship between the VExUS score - a measure of venous congestion obtained through ultrasound and right atrial pressure in pediatric patients with congenital heart disease.

4.Hence we aim to determine the correlation between the VExUS score and right atrial pressure in pediatric patients with congenital heart disease.

 
Close