| CTRI Number |
CTRI/2025/07/090471 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
comparison of femoral vein doppler with VEXUS score in critically ill patients |
|
Scientific Title of Study
|
Utility of femoral vein doppler to determine fluid overload in comparison to VEXUS score in critically ill patients : a prospective observational 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 Thomas Joseph |
| Designation |
DrNB resident |
| Affiliation |
BLK max superspecialty hospital |
| Address |
department of critical care medicine , blk max superspecialty hospital
Central
DELHI
110008
India |
| Phone |
7907752646 |
| Fax |
|
| Email |
dr.thomasjoseph990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradyut Bag |
| Designation |
principal consultant |
| Affiliation |
BLK max superspecialty hospital |
| Address |
department of crritical care medicine, blk max superspecialty hospital
Central
DELHI
110008
India |
| Phone |
9999879975 |
| Fax |
|
| Email |
pradyut.bag@blkhospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thomas Joseph |
| Designation |
DrNB rresident |
| Affiliation |
BLK max superspecialty hospital |
| Address |
department of critical care medicine, blk max superspecialty hospital
Central
DELHI
110008
India |
| Phone |
7907752646 |
| Fax |
|
| Email |
dr.thomasjoseph990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of critical care medicine, BLK MAX superspecialty hospital, Pusa road, Rajinder Nagar,Delhi India 110005 |
|
|
Primary Sponsor
|
| Name |
Dr Thomas Joseph |
| Address |
department of critical care medicine, blk max superspeciality hospital, pusa road, rajinder nagar, delhi, India 110005 |
| Type of Sponsor |
Other [no funding] |
|
|
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 |
| Dr Thomas Joseph |
blk max superspecialty hospital |
department of critical care medicine, blk max superspecialty hospital, pusa road, delhi
West
DELHI |
7907752646
dr.thomasjoseph990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLK MAX institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. patients above 18 years old and below 80 years old admitted in ICU. |
|
| ExclusionCriteria |
| Details |
1. Patients with length of ICU stay less than 48 hrs
2. Patients with inadequate window for USG.
3. Patients post abdominal surgery.
4. Patients with advanced intraabdominal malignancies
5. Patients in respiratory distress (respiratory rate more than 35/min, accessory muscles of respiration in use)
6. Patients with liver cirrhosis.
7. Patients with deep vein thrombosis of lower limb
8. Pregnant women.
9. Patients with advanced cardiac failure (decompensated heart failure, cardiogenic shock)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the correlation of Femoral Vein Doppler and VEXUS score in critically ill patients.
|
at zero hour, 24 hour, 48 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine correlation with other markers of fluid overload- lung B line score & generalized edema in clinical examination. |
at zero hour, 24 hour, 48 hour |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
01/08/2025 |
| 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="0"
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
|
After getting
scientific committee and ethical committee approval, a prospective comparative
observational study will be undertaken in the department of critical care
medicine, B L Kapur Memorial Hospital titled as “ Utility of femoral vein doppler to determine fluid
overload in comparison to VEXUS score in critically ill patients : A
prospective observational study” over a duration of 6 months. Data will be
collected through history, physical examination and Imaging (USG) and analyzed
with appropriate statistical methods.
|