FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/055931 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 26/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Venous Excess Ultrasound Score In The Assessment of Venous Congestion In Congenital Heart Disease Presenting with Heart Failure 
Scientific Title of Study   Comparison of Venous excess ultrasound score and Inferior Vena Cava Collapsibility index in the assessment of venous congestion in Congenital Heart Disease Presenting with Heart Failure 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma Thomas 
Designation  PG MD Paediatrics 
Affiliation  Jawaharlal nehru medical college 
Address  Department of Paediatrics Jawaharlal nehru medical college Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7306788369  
Fax    
Email  richu7emerald@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujata M Jali 
Designation  Professor 
Affiliation  Jawaharlal nehru medical college 
Address  Department of Paediatrics Jawaharlal nehru medical college Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9845688999  
Fax    
Email  drsmjali@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Reshma Thomas 
Designation  PG MD Paediatrics 
Affiliation  Jawaharlal nehru medical college 
Address  Department of Paediatrics Jawaharlal nehru medical college Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7306788369  
Fax    
Email  richu7emerald@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatrics,Jawaharlal nehru medical college Belagavi 
 
Primary Sponsor  
Name  Jawaharlal nehru medical college 
Address  Department of Paediatrics Jawaharlal nehru medical college Belagavi 
Type of Sponsor  Private medical college 
 
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 Reshma Thomas  KLEs Dr Prabhakar Kore hospital and research centre  Department of Paediatrics Jawaharlal nehru medical college Belagavi
Belgaum
KARNATAKA 
7306788369

richu7emerald@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All children from 2 months to 18 years of age admitted to Paediatric iCU and wards in KLE Dr Prabhakar Kore hospital, Belagavi with Congenital Heart disease presenting with heart failure 
 
ExclusionCriteria 
Details  1 Inadequate window

2 IVC Thrombus

3 Known case of cirrhosis with portal hypertension

4 Known case of acute or chronic renal failure 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare Venous Excess Ultrasound score VEXUS with Inferior Vena Cava Collapsibility index in the assessment of venous congestion in congenital heart disease presenting with heart failure  1 year hospital based study 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the correlation of Venous Excess Ultrasound score with clinical signs of right heart failure  1 year hospital based study 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/08/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Congenital heart disease (CHD) is the most common congenital anomaly in neonates occurring in 8 per 1,000 births is estimated that there are approximately 250,000 children born with CHD in India every year, CHD is the leading cause of deaths from non-communicable diseases (NCD) in paediatric population CHD deaths in 2019 in the world were 217,000. India, China, Pakistan, and Nigeria had the highest mortality, 39.7% of CHD deaths globally

Congestive heart failure(CHF) occur in CHDs due to hemodynamic change like low cardiac output or increased right atrial filling pressures Increased Right Atrial pressure gets transmitted back to peripheral veins causing congestion of abdominal organs and their dysfunction and thus alterations in organ venous flow quantified using color Doppler Clinical parameters of congestion include dyspnea, orthopnea. Jugular venous distension, edema, fatigue, crackles on auscultation, ascites Failure to thrive, nutritional deficiency, feeding difficulties are common presenting symptoms of congestive HF Persistent growth failure and cardiac dysfunction can also occur

Using Ultrasound, size and collapsibility index of Inferior Vena Cava(VC) determined for assessing Right Atrial Pressure(RAP). However venous congestion is mainly due to transmissions of pressure to peripheral organs. This alters the venous blood flow in portal, hepatic and renal veins which are quantified using Venous Excess Ultrasound Score Normal blood flow in the central veins, including the hepatic veins (HVs), is pulsatile in nature and that in the portal vein and the renal inter lobar vein is continuous or non pulsatile. The VEXUS score is determined first by assessing Inferior vena cava diameter then hepatic venous flow pattern type (S> D-normal, SD<-mild. S wave inversion severe) portal vein Doppler ultrasound to calculate Pulsatility index -Vmax- V min/Vmax 100 (<30% normal, 30-49% mild, >50% severe) and intrarenal flow (continuous-normal, biphasic-mild ,monophasic severe),

Grading of vexus Grade- 0 IVC<2cm- No significant congestion: Grade 1-IVC>2 cm with no hepatic/portal vein abnormality: Grade 2- 1VC-2cm with mild hepatic portal vein abnormality Grade 3- IVC>2cm with severe hepatic portal vein abnormality

This study is to assess venous congestion using Venous Excess Ultrasound in CHD patients presenting with heart failure and thereby help limit fluids in them to avoid organ dysfunction due to congestion .This study may help in preventing over treatment resulting in hypovolemia, Dyselectrolytemia and organ congestion ’VEXUS helps in making major clinical decisions like adjusting the dose of diuretics or inotropes in Heart failure and fluid management in critical phase of dengue fever and malaria VEXUS plays a major role in the prediction and management of Acute Kidney Injury
 
Close