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CTRI Number  CTRI/2025/04/084654 [Registered on: 13/04/2025] Trial Registered Prospectively
Last Modified On: 02/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the Use of VExUS along with Standard Care for Guiding fluid removal therapy in Children Aged 5-18 with Acute Kidney Injury: A Pilot Study  
Scientific Title of Study   Performance of VExUS with standard of care versus standard of care as guide for decongestive therapy in children with AKI in the age group of 5-18 Years – A Pilot, feasibility randomised control trial  
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 ATHIRA P 
Designation  SENIOR RESIDENT 
Affiliation  AIIMS BHOPAL 
Address  DISIVION OF PEDIATRIC NEPHROLOGY DEPARTMENT OF PEDIATRICS FIRST FLOOR AIIMS BHOPAL SAKET NAGAR BHOPAL MADHYPRADESH

Bhopal
MADHYA PRADESH
462020
India 
Phone  9746793207  
Fax    
Email  athirapgmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR GIRISH CHANADRA BHATT 
Designation  PROFESSOR 
Affiliation  AIIMS BHOPAL 
Address  DIVISION OF PEDIATRIC NEPHROLOGY DEPARTMENT OF PEDIATRICS AIIMS BHOPAL SAKET NAGAR MADHYAPRADESH

Bhopal
MADHYA PRADESH
462020
India 
Phone  8462002229  
Fax    
Email  drgcbhatt@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR AMBER KUMAR 
Designation  ADDITIONAL PROFESSOR 
Affiliation  AIIMS BHOPAL 
Address  DEPARTMENT OF PEDIATRICS AIIMS BHOPAL SAKET NAGAR MADHYAPRADESH

Bhopal
MADHYA PRADESH
462020
India 
Phone  9555954563  
Fax    
Email  amber.pediatrics@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
AIIMS BHOPAL 
 
Primary Sponsor  
Name  AIIMS BHOPAL 
Address  AIIMS BHOPAL SAKET NAGAR BHOPAL MADHYAPRADESH PIN 462020 
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 
ATHIRA P  AIIMS BHOPAL  FIRST FLOOR DIVISION OF PEDIATRIC NEPHROLOGY DEPARTMENT OF PEDIATRICS
Bhopal
MADHYA PRADESH 		 9746793207

athirapgmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee- Student Research(IHEC-SR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N17||Acute kidney failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard of care including physical examination of fluid overload and bed side lung ultrasonography  Standard of care of AKI in children include physical examination as per standard PICU protocol and lung ultrasonography repeated every 24 hourly till 7 day of enrolment in the study to decide on systemic venous congestion.Physical signs edema,ascitis, elevated JVP and presence of pulmonary edema were noted to target the decongestive therapy in patient. 
Intervention  Venous excess ultrasound(VExUS) is a bed side diagnostic test used to evaluate the systemic venous congestion in children with AKI  VExUS is a non invasive bed side doppler evalaution of inferior vena cava, hepatic vein, portal vein and renal vein to estimate systemic venous congestion. Based on the doppler pattern a VExUS score will be calculated.VExUS score ranges from zero to three.This evalaution will be done in addition to standard of care including physical examination and lung ultrasonography. And child decongestive measures will be targeted to keep VExUS score at or below 1. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 5 to 18 years with acute kidney injury (AKI) admitted in Pediatric department of AIIMS Bhopal 
 
ExclusionCriteria 
Details  i. All children with who are eligible, whose parents refuse to give written informed consent.
ii. Children diagnosed with CKD stage 3 or above.
iii. All children who are already diagnosed with chronic liver disease, Budd Chiari syndrome, moderate to severe tricuspid regurgitation, chronic pulmonary hypertension.
iv. All children who anatomical abnormality of liver
v. All children with renal vascular abnormality, gross hydronephrosis and cystic kidney disease
vi. All children who had received RRT prior to hospital admission

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Renal replacement therapy free days during the initial 28 days in children with Acute Kidney Injury
Mortality in children with Acute Kidney injury in both groups 		 28 days after diagnosis of AKI in child 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the correlation of VExUS score with need of RRT
 		 Initial 28 days after diagnosing Acute kidney injury in child  
To evaluate the requirement of total diuretic dose in both groups  Initial 7 days after diagnosing Acute kidney injury in child 
Cumulative fluid overload in both the group at the end day 7 of enrolment  Initial 7 days after diagnosing Acute kidney injury in child 
To evaluate the occurrence Intradialytic hypotension in children with AKI receiving RRT in both group  Initial 7 days after diagnosing Acute kidney injury in child 
To evaluate the proportion of children with AKI developing dyselectrolytemia (in terms of sodium, potassium and calcium disturbances) in both groups.  Initial 7 days after diagnosing Acute kidney injury in child 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 3 
Date of First Enrollment (India)   14/04/2025 
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="6"
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   Assessment of volume status is critical in all children with Acute kidney injury (AKI). Peripheral signs of fluid overload did not correlate with AKI, which reemphasizes the fact that they might not truly reflect  the intravascular volume status. Central venous pressure  determination is an invasive procedure and it’s values  can be influenced by  various factors. Over  the past years point of care ultra sound (POCUS) is identified  as a non invasive bedside  monitor for evaluating venous congestion and this  helps to monitor  the response  to decongestive therapy .Venous excess ultrasound (VExUS)  is emerging as a valuable bed side tool to gain real time hemodynamic insights. The present  study  aimed to establish the usefulness of the VExUS  score in children with AKI for detecting systemic venous congestion and directing the decongestive therapy in comparison with current standard of care for AKI in children .To date there is paucity of literature on applicability and usefullnes of VExUS score a an estimator of the degree of venous congestion in pediatric patients. This study will be one of  the first in evaluation of performance and utility of VExUS in children. 
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