FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/09/057208 [Registered on: 01/09/2023] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Does VExUS ultrasound help in fluid management in ICU? 
Scientific Title of Study   VExUS(Venous Excess Ultrasound score)guided de-resuscitation versus routine fluid management in critically ill patients: Double blinded Randomized Control Study 
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 Swagata Tripathy 
Designation  Professor and HOD 
Affiliation  All India Institute of Medical Sciences Bhubanewsar 
Address  room 406, academic building, department of anesthesiology and critical care, Sijua, Patrapada, Khordha, Orissa-751019

Khordha
ORISSA
751019
India 
Phone  8763400534  
Fax    
Email  tripathyswagata@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swagata Tripathy 
Designation  Professor and HOD 
Affiliation  All India Institute of Medical Sciences Bhubanewsar 
Address  room 406, academic building, department of anesthesiology and critical care, Sijua, Patrapada, Khordha, Orissa-751019

Khordha
ORISSA
751019
India 
Phone  8763400534  
Fax    
Email  tripathyswagata@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumana S 
Designation  junior resident academic 
Affiliation  All India Institute of Medical Sciences 
Address  room 406, academic building, department of anesthesiology and critical care, Sijua, Patrapada, Khordha, Orissa-751019

Khordha
ORISSA
751019
India 
Phone  9036659188  
Fax    
Email  sumanasuresh18@gmail.com  
 
Source of Monetary or Material Support  
AIIMS BHUBANESWAR, Sijua, Patrapada, Khordha, Odisha-751019 
 
Primary Sponsor  
Name  AIIMS, Bhubaneswar 
Address  AIIMS, sijua, patrapada , odhisha-571019 
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 Swagata Tripathy  AIIMS Bhubaneswar  room 406, academic building, department of anesthesiology and critical care, Sijua, Patrapada, Khordha, Orissa-751019
Khordha
ORISSA 		 8763400534

tripathyswagata@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhubaneswar Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  De-resuscitation based on clinical discretion  patients randomized to Non VExUS group will receive treatment based on clinicians discretion. No active intervention will be done from research team. management will be based on clinical discretion of treating team. 
Intervention  De-resuscitation based on VExUS grading  patients randomized to VExUS group will receive de-resuscitation based on VExUS grading algorithm. if IVC 2cm patient will be recruited, hepatic venous doppler, portal venous doppler, renal vein doppler will be performed. based on the grading de- resuscitation will be started -24 hours neutral to negative balance, addition of furosemide , torsemide, spironolactone, or renal replacement therapy based on the severity of fluid overload. after recruitment initial prescription of tablet torsemide 10mg and spironolactone 50 mg and 0.25mg/kg of furosemide IV bolus will be given on day one. if still fluid overload persists, Furosemide infusion will be started at the rate of 2.5mg/hour net 6 hourly fluid balance will be checked, if 250ml negative furosemide infusion rate will be doubled. if net 6 hourly fluid balance is 250-750 ml negative then same regimen will be continued till day 5. if net 6 hourly balance is 750ml negative then half furosemide infusion rate till 1.25mg/hour is reached. infusion will be stopped if 750ml negative balance is achieved  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  adults >18 years admitted in SICU/CICU/HDU.
patients requiring aggressive fluid resuscitation in 24 hours .
expected ICU stay > 48 hours
Inferior vena cava diameter > 2 cm at any point of ICU stay after 24 to 48 hours post admission. 
 
ExclusionCriteria 
Details  refusal to give consent
known cases of cirrhosis with portal hypertension and IVC thrombus.
pregnant
inadequate acoustic window
prediction of ICU stay less than 48 hours in ICU/HDU
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the cumulative fluid balance on day 4 of recruitment between the intervention group & control group ( measured in ml, expressed as mean with SD)  day 4 of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
cumulative fluid balance on days 3 & 5 of recruitment
organ failure indices -p/f ratio, serum creatinine, Delta SOFA score
duration of mechanical ventilation in hours
length of ventilation in hours
incidence of new onset hypernatremia and metabolic alkalosis
mortality at ICU/ward 		 day 3 & day 5 post recruitment  
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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 4 
Date of First Enrollment (India)   11/09/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
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   Previous studies have demonstrated a dose dependent relationship between positive fluid balance and mortality and length of ICU stay. fluid accumulation increases interstitial pressure, compromises organ flow, more pronounced in encapsulated organs like liver and kidneys.
De-resuscitation of patients with fluid overload is associated with reduced mortality in critical illness. Active De-resuscitation based on clinical end points of fluid overload may be fallacious.
VExUS grading aims to achieve euvolemic state by removing excess fluid and preventing fluid overload. 
This thesis will propose a standardized protocol for ultrasound guided fluid de resuscitation based on the assessment of VExUS grading.
We hypothesis that VExUS ( Venous Excess Ultrasound Score) guided de-resuscitation reduces cumulative fluid balance compared to routine fluid management in critically ill patients.
 
Close