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CTRI Number  CTRI/2024/11/076210 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 11/04/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Advanced Assessment of Fluid resuscitation in ICU patients with use of VEXUS, E-VEXUS and Lung Ultrasound  
Scientific Title of Study   Enhanced Assessment of Fluid resuscitation in ICU :role of VEXUS, E- VEXUS and Lung Ultrasound 
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 Swati Taneja 
Designation  Senior Resident 
Affiliation  Institute of Medical Sciences, Banaras Hindu University  
Address  Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9478906270  
Fax    
Email  tanejaswati91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Raj Pandey 
Designation  Associate Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University  
Address  Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  7704094669  
Fax    
Email  drarunrajpandey@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun Raj Pandey 
Designation  Associate Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University  
Address  Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  7704094669  
Fax    
Email  drarunrajpandey@gmail.com  
 
Source of Monetary or Material Support  
Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005 
 
Primary Sponsor  
Name  Department of Anaesthesiology IMS BHU  
Address  Institute of Medical Sciences, Banaras Hindu University, Varanasi  
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 
Dr Swati Taneja  Sir Sundar Lal Hospital, Institute of medical sciences, Banaras Hindu university   CSSB , ICU ,IMS ,BHU , Varanasi
Varanasi
UTTAR PRADESH 		 9478906270

tanejaswati91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY VARANASI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All Patients admitting in ICU and Patients who aged 18 years or older with sepsis, poisoning , meningitis, encephalitis in shock
 
 
ExclusionCriteria 
Details  1. patient relatives who will not give consent
2.Patients with Liver failure.

3. Patients with pneumonia, ARDS, pleural effusion.

4. Patients with cardiogenic shock

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to evaluate whether incorporating extended VEXUS score into the existing VEXUS protocol with lung ultrasound score (LUS) enhances the sensitivity and timely identification of fluid overload in ICU patients.  BASELINE, 1 HOUR , 3 HOUR , 6 HOUR , 12 HOUR , 24 HOUR , 48 HOUR  
 
Secondary Outcome  
Outcome  TimePoints 
 To evaluate the possible relation between the extended VEXUS with VEXUS grade with B line Ultrasound and the adverse effects of intensive fluid administration  POCUS will be performed at 1 hour, 3 hour , 6 hour ,12 hour, 24 hours till 48 hours  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/11/2024 
Date of Study Completion (India) 30/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  		 Patient with hypotension with MAP less than 60 mm Hg, will be screened further, the patients with IVC collapsibility index of more than 50 % or distensibility index of more than 18% with IVC diameter of less than 2 cm and who meet all the inclusion criteria will be resuscitated with fluid bolus of 20 ml /kg over an hour , if the patient doesn’t respond  then another fluid bolus of 10 ml/kg will be given . If the patients starts responding to fluids , then the maintenance fluids will be given . Following this, POCUS will be performed at 1st hour , 3rd hour, 6th hour , 12th hour , 24 hour till 48 hours to look for IVC distensibility or collapsibility index with diameter and lung ultrasound for B-Lines evaluation .If the IVC diameter is more than 2 cm with distensibility index of less than 18% or collapsibility index of less than 50%  , then we will perform VEXUS with femoral vein for Extended VEXUS to look for venous congestion and associated organ dysfunction .Then the final score of mild, moderate and severe will be calculated by adding B- line lung ultrasound score, with VEXUS and extended VEXUS score. 
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