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CTRI Number  CTRI/2024/12/078167 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 13/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing early fluid removal guided by ultrasound examination vs usual practice in children admitted to ICU and on ventilator  
Scientific Title of Study   Early deresuscitation guided by VExUS vs conventional practice in mechanically ventilated children in PICU a randomised controlled trial 
Trial Acronym  EDVEx 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prasanna Samynathan 
Designation  Senior Resident 
Affiliation  PGIMER: Post Graduate Institute of Medical Education and Research 
Address  Level-3, APC-3B, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9159394955  
Fax    
Email  samyannampras@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Karthi Nallasamy 
Designation  Associate Professor 
Affiliation  PGIMER: Post Graduate Institute of Medical Education and Research 
Address  Level 3, APC 3A, PGIMER, Chandigarh
Advanced Pediatrics Centre
Chandigarh
CHANDIGARH
160012
India 
Phone  9814376716  
Fax    
Email  ny.karthi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Karthi Nallasamy 
Designation  Associate Professor 
Affiliation  PGIMER: Post Graduate Institute of Medical Education and Research 
Address  Level 3, APC 3A, PGIMER, Chandigarh
Advanced Pediatrics Centre
Chandigarh
CHANDIGARH
160012
India 
Phone  9814376716  
Fax    
Email  ny.karthi@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate institute of medical education and research Chandigarh 
 
Primary Sponsor  
Name  NIL 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Karthi Nallasamy  PGIMER  Level 3, APC 3B PICU, PGIMER, Chandigarh
Chandigarh
CHANDIGARH 		 9814376716

ny.karthi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard care  Standard care will be administered and deresuscitation will be based on existing unit protocol at the discretion of treating physician 
Intervention  Venous excess ultrasound (VExUS) assessment  Children will undergo ultrasound evaluation to calculate VExUS score and will be started on furosemide infusion in a protocolised manner depending on the VExUS score. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Mechanically ventilated and hemodynamically stable without escalation of vasoactives and requirement of fluid bolus in the previous twelve hours 
 
ExclusionCriteria 
Details  Right ventricular dysfunction
Already on furosemide therapy
Chronic kidney disease cirrhosis portal vein thrombosis
Anticipated mechanical ventilation less than two days
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
28-day ventilation free days  Number of days free of invasive ventilation from day 0 of randomization till day 28 of randomization
Death or discontinuation of care will be recorded as 0 
 
Secondary Outcome  
Outcome  TimePoints 
Cumulative fluid overload percentage  At the end of day 5 of PICU stay 
Incidence of new/progressive AKI  Till 28 days after randomisation or till discharge from PICU or death, whichever is earlier 
Oxygenation index until 72 hours after enrolment  Until 72 hours of enrolment 
Organ dysfunction scores until 72 hours after enrolment  Until 72 hrs of enrolment 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   01/01/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [samyannampras@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Children aged from 1 year to 12 years admitted to PICU for any reason who are mechanically ventilated and hemodynamically stable (MAP >5th centile and no fluid bolus/escalation of vasoactives for atleast 12 hrs) will be eligible for enrolment. Children with  Right Ventricular dysfunction, already on Furosemide, anticipated mechanical ventilation for <48h, AKI KDIGO Stage 3, Severe chronic kidney disease/Cirrhosis/Portal vein thrombosis will be excluded from the study.Enrolled Children will be randomised into either VExUS group or Conventional group. In children being randomised to VExUS group, VExUS Score will be done every 12hours or every 24 hrs (if the initial VExUS score is 0) upto 72 hours of PICU stay. Children with no signs of venous congestion (i.e. VExUS =0) will not be given furosemide infusion and further screening will be done every 24 hrs up to 72 hrs of admission. If VExUS score is 1, continuous infusion of intravenous furosemide at a dose of 0.05mg/kg/hour will be initiated. If VExUS Score is 2 or 3, continuous infusion of intravenous furosemide at a dose of 0.1 mg/kg/hour will be initiated. VExUS score will be performed every 12 hours to monitor for improvement/worsening in venous congestion in children initiated on furosemide infusion. If there is no improvement/worsening in VExUS score at 24 hours of infusion, the infusion dose is doubled. If there is reduction of at least one point in VExUS score at 24 hours after infusion, the furosemide infusion will be continued at the 28 same dose. Frusemide infusion will be discontinued if VExUS score decreased to 0 [for children with initial score of 1 and 2] or 1 [for children with initial score of 3]. In case of the following conditions, Furosemide infusions will be discontinued: Signs of hypoperfusion, Sodium>160mEq/L, metabolic alkalosis(HCo3 >35mEq/L), Severe hypokalemia (<2.5mEq/L).In patients randomised to the Conventional group, based on the clinical assessment and/or fluid overload percentage, the treating team will decide whether to prescribe furosemide or not. As per our unit‘s current practice, Furosemide infusion will be considered at 0.05-0.1mg/kg/hr if fluid overload percentage is high and/or associated clinical evidence of fluid overload. The primary outcome is number of the 28-day ventilation free days. The Secondary outcomes include cumulative fluid overload percentage on day 5 of PICU stay, incidence of new/progressive AKI, oxygenation index until 72 hours after enrolment and organ dysfunction scores until 72 hours after enrolment 
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