| CTRI Number |
CTRI/2024/03/063672 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The role of Vexus(Venous Excess Ultrasonography) in the management of patients in ICU |
|
Scientific Title of Study
|
Clinical applications of the Venous excess ultrasonography (VeXus): 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 Pankaj Kumar |
| Designation |
DRNB RESIDENT CCM |
| Affiliation |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCE |
| Address |
Critical care Dept. 4th floor room no 2
Raipur
CHHATTISGARH
492001
India |
| Phone |
7979090084 |
| Fax |
|
| Email |
secrecy143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prafulla Agnihotri |
| Designation |
HOD CCM |
| Affiliation |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCE |
| Address |
Critical care dept. 4th floor room no 2
Raipur
CHHATTISGARH
492001
India |
| Phone |
9300206471 |
| Fax |
|
| Email |
prafullaagnihotri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
DRNB RESIDENT CCM |
| Affiliation |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCE |
| Address |
Dept. of Critical care , room no 2 , 4th Floor , SBIMS ,Mowa,Dubey colony
Raipur
CHHATTISGARH
492001
India |
| Phone |
7979090084 |
| Fax |
|
| Email |
secrecy143@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Balaji Institute of Medical Science,Dubey,Colony,Mowa, Raipur Chhatisgarh |
|
|
Primary Sponsor
|
| Name |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCE |
| Address |
Dubey Colony Mowa Raipur Chhatisgarh |
| Type of Sponsor |
Private 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 |
| Dr Pankaj Kumar |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCE |
Critical Care Dept.,4th floor , room no 2
Raipur
CHHATTISGARH |
7979090084
secrecy143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Balaji Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I503||Diastolic (congestive) heart failure, |
|
|
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.Age ≥18 years
2.Presence of clinical signs of fluid overload.
3.Need loop diuretic therapy for decongestion.
|
|
| ExclusionCriteria |
| Details |
1.Prior Diuretic therapy
2.Pregnancy
3.Unstable Hemodynamics
4.Acute Coronary Disease
5.CPR with in 24 hrs
6.Chronic Liver Disease with Portal Hypertension and Tricuspid Disease interfering Portal Vein Assessment.
7.Permanent Atrial Fibrillation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome of my study will aim to use find venous congestion in patients with clinical and radiological signs of fluid overload. |
Assessment will be done on daily basis till normalisation of Venous congestion and then every third day till Icu discharge or death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Congestion grading(Using Vexus score) and different organ involvement.
2. Diuretic response in venous congestion as improvement in VeXus Score.
3. Weaning day from mechanical respiratory support.
4. ICU length .
5. Hemodynamics after vexus guided fluid desuscitation
|
one year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/03/2024 |
| 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="1"
Months="0"
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
|
Changes in Doppler flow patterns of hepatic veins (HV), portal vein (PV) and intra-renal veins (RV)
reflect right atrial pressure and venous congestion.Beaubien-Souligny et al. proposed a venous excess Doppler Ultrasound (Vexus) grading system to quantify organ congestion. Using this novel concept , my study will aim to stablish venous congestion if any pre and post fluid therapy in different patients in ICU falling under inclusion criteria. Moreover this Vexus Score will also be used to find the role and responsiveness of Diuretic therapy in Venous congestion. |