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CTRI Number  CTRI/2026/03/105645 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 03/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A new ultrasound method to monitor fluid overload in patients with severe infection 
Scientific Title of Study   Prognostic role of VExLUS score in addressing fluid overload in sepsis patients in a tertiary care centre.” 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  parvathi 
Designation  junior resident 
Affiliation  government thoothukudi medical college 
Address  department of emergency medicine , government thoothukudi medical college,Thoothukudi
department of emergency medicine ,government thoothukudi medical college, thoothukudi
Toothukudi
TAMIL NADU
628008
India 
Phone  9944598703  
Fax    
Email  drparvathi37@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  vijayalakshmi 
Designation  Senior Resident 
Affiliation  government thoothukudi medical college 
Address  Department of Emergency Medicine,Government Medical College,Thoothukudi
Department of Emergency Medicine,Government Medical College,Thoothukudi

TAMIL NADU
628008
India 
Phone  8903514505  
Fax    
Email  aarvee93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vijayalakshmi 
Designation  senior resident 
Affiliation  government thoothukudi medical college 
Address  Department of Emergency Medicine,Government Medical College,Thoothukudi
Department of Emergency Medicine,Government Medical College,Thoothukudi
Toothukudi
TAMIL NADU
628008
India 
Phone  8903514505  
Fax    
Email  aarvee93@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Government Thoothukudi Medical College 
Address  Medical College Road Kamaraj Nagar 3rd Mile Thoothukudi Tamil Nadu 628008. 
Type of Sponsor  Government medical college 
 
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 
vijayalakshmi  government thoothukudi medical college  Room no 5, Institutional ethics committee,Government thoothukudi medical college
Toothukudi
TAMIL NADU 
8903514505

aarvee93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee,thoothukudi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients greater than 18 years old
Life-threatening organ dysfunction
Patients with diagnosis of sepsis confirmed by SIRS criteria
 
 
ExclusionCriteria 
Details  Refusal to participate
Pregnant patients
Patients already on hemodialysis
Patients with previously known conditions that interfere with portal Doppler assessments, namely liver cirrhosis, or severe tricuspid regurgitation with structural heart disease. If any of these conditions are identified during the present episode, the patient would also be excluded.
Age lesser than 18 years
Hemodynamic instability due to active hemorrhage
Poor echogenicity for ultrasound window
Acute coronary syndrome
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To evaluate the role of VExLUS score as a prognostic marker in septic patients thus providing greater sensitivity and earlier identification of fluid overload. This guides clinicians to decide on whether to administer supplemental fluid therapy or suspend its administration  At baseline and at discharge 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate the possible relation between the different VExLUS grades & the adverse effects of intensive fluid administration & diuretic use & the need of thoracocentesis & paracentesis need for renal replacement therapy
To Identify the possible association between higher VExLUS score & length of ICU stay & mortality
 
At baseline & at discharge
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   14/03/2026 
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 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 - NO
Brief Summary  

Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection which is associated with an in-hospital mortality greater than 10%.

Septic shock is a subset of sepsis with manifest circulatory dysfunction (use of vasopressors and persistent elevation of lactic acid), in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality (hospital mortality rates greater than 40%).

Currently, in addition to the use of empiric antibiotics and control of the infectious focus, intravenous fluid therapy is an essential intervention to promote hemodynamic stabilization.

 However, observational studies describe worse outcomes related to fluid overload and increased mortality and greater use of fluid-related medical interventions such as thoracentesis, paracentesis, hemodialysis, and use of diuretics in Sepsis.

Hemodynamic management in critically ill patients has traditionally focused on maintaining adequate cardiac output and arterial blood pressure by relying on fluid administration and/or vasopressor/inotropic support. However, organ perfusion is affected by other important factors, such as venous pressure, which can be overlooked.

The development of clinically significant organ congestion is susceptible to occur in patients with right ventricular failure or pulmonary hypertension, and in patients with fluid overload.

These contributors are likely to be synergistic in critically ill patients, particularly when renal dysfunction aggravates fluid retention.

A reduction of the arteriovenous gradient across vital organs may hamper adequate perfusion. Fluid overload influences tissue perfusion in the presence of venous congestion and tissue edema.

The evaluation of lung congestion with point of care ultrasound , as a signal of extravascular fluid, and, more recently,a venous excess Doppler ultrasound VExUS grading system, are parameters for the assessment of the fluid status of the patient and organ congestion.

 
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