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CTRI Number  CTRI/2024/08/072093 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 11/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of role of Venous Excess Ultrasound-VExUS grading system in reducing complications in critically ill patients during dialysis 
Scientific Title of Study   Evaluation of role of VEXUS score in reducing intradialytic complications in critically ill patients-A randomized controlled 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  Ninu Rose Paul 
Designation  PG student 
Affiliation  Pushpagiri Institute of Medical Sciences and Research Centre 
Address  PG student DRNB resident Department of Critical Care Medicine Pushpagiri Institute of Medical Sciences and Research Centre Tiruvalla

Pathanamthitta
KERALA
689101
India 
Phone  7736142602  
Fax    
Email  ninurp15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mathew Pulicken 
Designation  Guide - Professor and Head of Department  
Affiliation  Pushpagiri Institute of Medical Sciences and Research Centre 
Address  Department of Critical Care Medicine Pushpagiri Institute of Medical Sciences and Research Centre Tiruvalla

Pathanamthitta
KERALA
689101
India 
Phone  7736883088  
Fax    
Email  pulicken@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR Mathew Pulicken 
Designation  Guide - Professor and Head of Department  
Affiliation  Pushpagiri Institute of Medical Sciences and Research Centre 
Address  Department of Critical Care Medicine Pushpagiri Institute of Medical Sciences and Research Centre Tiruvalla

Pathanamthitta
KERALA
689101
India 
Phone  7736883088  
Fax    
Email  pulicken@yahoo.com  
 
Source of Monetary or Material Support  
Pushpagiri Institute of Medical Sciences and Research Centre Tiruvalla Pathanamthitta kerala India PIN:689101 
 
Primary Sponsor  
Name  Ninu Rose Paul 
Address  DRNB Resident Department of Critical Care Medicine Pushpagiri Institute of Medical Sciences and Research Centre Tiruvalla Kerala PIN:689101 
Type of Sponsor  Other [SELF] 
 
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 
Ninu Rose Paul  Pushpagiri Institute of Medical Sciences and Research Centre  DRNB Resident Department of Critical Care Medicine Tiruvalla
Pathanamthitta
KERALA 		 7736142602

ninurp15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PUSHPAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N17-N19||Acute kidney failure and chronic kidney disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  traditional clinical methods  Traditional clinical methods are used to determine ultrafiltration goals prior to dialysis and intradialytic complications are assessed duration: 5 minutes of assessment 
Intervention  Venous Excess Ultrasound - VExUS Grading system   Venous Excess Ultrasound - VExUS Grading system is used along with traditional clinical methods to modify ultrafiltration goals prior to dialysis and intradialytic complications are assessed Duration:5 minutes of assessment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  admission in ICU requiring dialysis 
 
ExclusionCriteria 
Details  previous echocardiographic evidence of right heart dysfunction
previous liver resection or transplantation
liver cirrhosis
pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
incidence of intradialytic complications between traditional and VEXUS score guided ultrafiltration goals  1 HOUR
2 HOUR
3 HOUR
4 HOUR 
 
Secondary Outcome  
Outcome  TimePoints 
number of dialysis sessions required in ICU
Number of ICU days
number of ventilator days
ICU mortality
30 day mortality 		 24 hours
48 hours
72 hours
30 days 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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)   20/08/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This review aims to evaluate if the VEXUS score can improve outcomes by guiding ultrafiltration in critically ill patients undergoing hemodialysis compared to conventional methods. Conventional fluid assessment in such patients is often challenging and can lead to complications from inaccurate ultrafiltration. The primary objective is to assess the incidence of intradialytic complications. Secondary objectives include comparing the number of dialysis sessions, ICU days, ventilator days, ICU mortality, and 30-day mortality between the VEXUS-guided and traditional ultrafiltration groups. The study seeks to clarify whether the VEXUS score offers a more effective approach in managing fluid removal in this vulnerable patient population. 
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