| CTRI Number |
CTRI/2025/03/083686 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluate the utility of VEXUS score as a marker for acute kindey injury in patients of septic shock. |
|
Scientific Title of Study
|
Evaluation of VEXUS score as a marker for acute kidney injury in patients of septic shock. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Kumar Sharma |
| Designation |
DrNB resident |
| Affiliation |
Department of critical care medicine, Max super-speciality hospital, Saket, New Delhi |
| Address |
Department of critical care medicine, Max super-speciality hospital, press enclave road, Saket, South, New Delhi.
110017
India
South
DELHI
110017
India |
| Phone |
9968473703 |
| Fax |
|
| Email |
Dr.rahulsharma1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Omender Singh |
| Designation |
Principal director |
| Affiliation |
Max super-speciality hospital, Saket, New Delhi |
| Address |
Department of critical care medicine, Max super-speciality hospital, press enclave road, Saket, South, New Delhi.
110017
India
South
DELHI
110017
India |
| Phone |
9810734246 |
| Fax |
|
| Email |
Omender.Singh@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Omender Singh |
| Designation |
Principal director |
| Affiliation |
Max super-speciality hospital, Saket, New Delhi |
| Address |
Department of critical care medicine, Max super-speciality hospital, press enclave road,
Saket, South, New Delhi.
110017
India
South
DELHI
110017
India |
| Phone |
9810734246 |
| Fax |
|
| Email |
Omender.Singh@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Max super-speciality hospital, Saket, New Delhi |
|
|
Primary Sponsor
|
| Name |
Max superspeciality hospital |
| Address |
Department of critical care medicine, Max Super-speciality hospital, press enclave road,
Saket, South, New Delhi.
110017
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rahul Kumar Sharma |
Max super-speciality Hospital , Saket, New Delhi |
Medical ICU 6th floor, Department of critical care medicine, Max super-speciality hospital, press enclave, Saket, South, New Delhi, 110017, INDIA
South
DELHI |
9968473703
Dr.rahulsharma1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N178||Other acute kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
-Patients who fulfil the septic shock definition according to the Sepsis-3 consensus conference.
|
|
| ExclusionCriteria |
| Details |
-Patient’s refusal to participate.
-Patients in which more than 4 hours have elapsed since diagnosis of septic shock.
-Anticipated to undergo immediate surgery.
-Hemodynamic instability due to active haemorrhage.
-Patients with previously known conditions that interfere with Doppler assessments, namely liver cirrhosis.
Pregnancy
Chronic Kidney Disease (CKD) patients on Haemodialysis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of utility of VEXUS score as a marker for acute kidney injury in patients with septic shock.
|
Will be observed till patient is admitted in intensive care unit.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Correlation of VEXUS score with need of renal replacement therapy in sepsis patients.
2.Correlation of VEXUS score with intensive care unit mortality.
3.Need of renal replacement therapy in sepsis induced acute kidney injury patients.
4.Duration of intensive care unit stay.
|
Will be observed till patient is admitted in intensive care unit. |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
15/04/2025 |
| 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="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
|
Septic shock is defined as a subset of sepsis in which particularly profound circulatory, cellular and metabolic abnormalities are associated with greater risk of mortality. Venous congestion is a promising physiological marker that may be able to help direct resuscitation of patients with septic shock. Venous congestion is an important haemodynamic state in sepsis patients because it is associated with impaired organ function, particularly acute kidney injury. Therefore, we intend to evaluate of VEXUS score as a marker for acute kidney injury in patients of septic shock. |