| 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
|
|
|
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
|
|
|
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
|
|
|
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. |