| CTRI Number |
CTRI/2022/10/046438 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
07/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Among icu patients with infections, to identify patients with excess fluid, using ultrasound score |
|
Scientific Title of Study
|
Use of vexus score to identify prevalence of venous congestion in patients admitted with sepsis to the ICU |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JUBIN JOHN |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ST. JOHNS MEDICAL COLLEGE |
| Address |
DEPT OF CRITICAL CARE,
ST JOHNS MEDICAL COLLEGE AND HOSPITAL, BANGALORE
ST JOHNS MEDICAL COLLEGE AND HOSPITAL, BANGALORE
Bangalore
KARNATAKA
560034
India |
| Phone |
07696416815 |
| Fax |
|
| Email |
jubin.cmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
CAROL SHAYNE DSILVA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ST. JOHNS MEDICAL COLLEGE |
| Address |
DEPT OF CRITICAL CARE,
ST JOHNS MEDICAL COLLEGE AND HOSPITAL, BANGALORE
ST JOHNS MEDICAL COLLEGE AND HOSPITAL, BANGALORE
Bangalore
KARNATAKA
560034
India |
| Phone |
09766397569 |
| Fax |
|
| Email |
calps80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JUBIN JOHN |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ST. JOHNS MEDICAL COLLEGE |
| Address |
DEPT OF CRITICAL CARE,
ST JOHNS MEDICAL COLLEGE AND HOSPITAL, BANGALORE
ST JOHNS MEDICAL COLLEGE AND HOSPITAL, BANGALORE
KARNATAKA
560034
India |
| Phone |
07696416815 |
| Fax |
|
| Email |
jubin.cmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| ST JOHNS MEDICAL COLLEGE AND HOSPITAL, BANGALORE |
|
|
Primary Sponsor
|
| Name |
JUBIN JOHN |
| Address |
DEPT. OF CRITICAL CARE,
ST JOHNS MEDICAL COLLEGE AND HOSPITAL, BANGALORE |
| Type of Sponsor |
Other [self] |
|
|
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 |
| CAROL SHAYNE DSILVA |
ST JOHNS MEDICAL COLLEGE |
DEPT OF CRITICAL CARE, ST JOHNS MEDICAL COLLEGE AND HOSPITAL
Bangalore
KARNATAKA |
09766397569
calps80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ST.JOHNS MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, (2) ICD-10 Condition: J181||Lobar pneumonia, unspecified organism, (3) ICD-10 Condition: J14||Pneumonia due to Hemophilus influenzae, (4) ICD-10 Condition: J150||Pneumonia due to Klebsiella pneumoniae, (5) ICD-10 Condition: J13||Pneumonia due to Streptococcus pneumoniae, (6) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, (7) ICD-10 Condition: J129||Viral pneumonia, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
all consenting >18years old, admitted to medical ICU with diagnosis of sepsis (as per SEPSIS3) |
|
| ExclusionCriteria |
| Details |
Inadequate ultrasound window,inferior vena cava thrombus, known case of cirrhosis with portal hypertension, portal vein thrombosis, liver transplant, chronic kidney disease stage 5 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify patients in sepsis with venous congestion |
Day 0, day1, day2, day3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to identify patients with venous congestion in patients with sepsis that develop AKI |
Day 0, day1, day2, day3 |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
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)
|
15/10/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
patients in ICU with sepsis receive a lot of iv fluids. Positive fluid balance has been associated with poor outcomes, including AKI. venous congestion due to positive fluid balance, causing reduction in tissue perfusion could be one of the causes for the same. VeXuS score has been proposed to identify venous congestion in ICU. Using the same, I would like to identify the prevalence of venous congestion in ICU and AKI. |