| CTRI Number |
CTRI/2025/12/098377 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical research to identify early signs of kidney failure using ultrasound scan of abdomen |
|
Scientific Title of Study
|
Correlation of Venous Excess Ultrasound (VExUS) with Acute Kidney
Injury Progression in ICU Patients with 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 |
ABHISHEK R |
| Designation |
PROFESSOR |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology, Dr Moopens Medical College, Naseera Nagar, Meppadi (PO), Wayanad
Wayanad
KERALA
673577
India |
| Phone |
7795460038 |
| Fax |
|
| Email |
dr.abhishek.rajanaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ABHISHEK R |
| Designation |
PROFESSOR |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology, Dr Moopens Medical College, Naseera Nagar, Meppadi (PO), Wayanad
Wayanad
KERALA
673577
India |
| Phone |
7795460038 |
| Fax |
|
| Email |
dr.abhishek.rajanaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PREETHI R N |
| Designation |
Assistant Professor |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology, Dr Moopens Medical College, Naseera Nagar, Meppadi (PO), Wayanad
Wayanad
KERALA
673577
India |
| Phone |
8277623335 |
| Fax |
|
| Email |
preethi9010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Moopens Medical College, Naseera Nagar, Meppadi (P.O),Wayanad, Kerala, India Pin- 673577 |
|
|
Primary Sponsor
|
| Name |
Dr Moopens Medical College, Wayanad |
| Address |
Dr Moopens Medical College, Naseera Nagar, Meppadi (P.O),Wayanad, Kerala, India Pin- 673577 |
| 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 ABHISHEK R |
Dr Moopens Medical College |
Department of Anaesthesiology, 7th floor, Naseera Nagar, Meppadi (P.O),Wayanad, Kerala, India. Pin code- 673577
Wayanad
KERALA
Wayanad
KERALA |
7795460038
dr.abhishek.rajanaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Moopens Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group V |
Patients with septic shock
BP Mean arterial pressure less than 65.
Patient on ionotropic and vasopressor support.
Serum lactate more than 2 mmol per litre |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of septic shock as per Sepsi 3 definition of 2021, Persistent hypotension requiring vasopressors to maintain MAP more than 65 mmHg, and Serum lactate more than 2 mmol/L despite adequate fluid resuscitation, Septic shock due to bacterial, viral, or tropical infections (example- dengue, leptospirosis, malaria, scrub typhus) |
|
| ExclusionCriteria |
| Details |
Pre-existing end-stage renal disease on dialysis, Severe pre-existing right heart failure, severe tricuspid regurgitation, Poor echocardiographic window precluding adequate VExUS assessment, Left ventricular ejection fraction (LVEF) less than 30 percent and Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establish whether higher VExUS scores are significantly associated with AKI progression in septic shock patients. |
Baseline values will be recorded on admission to the ICU as time zero,
followed by 24 hours, 48 hours & 72 hours of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of VExUS scan with need for dialysis |
Baseline values will be recorded on admission to the ICU as time zero,
followed by 24 hours, 48 hours & 72 hours of admission |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
16/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In 110 patients, Bedside ultrasound scan of the abdomen called VExUS scoring scan which is the ultrasound scan of inferior venacava, renal and hepatic veins and portal vein will be performed by icu doctors within 24 hours of septic shock diagnosis and repeated at 48 hours and 72 hours. Standard ICU management will be followed according to the Surviving Sepsis Campaign guidelines to treat the patients in septic shock. |