| 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
|
|
|
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
|
|
|
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 |