| CTRI Number |
CTRI/2025/12/098489 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective, observational study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of administering fluid on kidney function based based on ultrasound guidance in patients admitted with severe infection |
|
Scientific Title of Study
|
Impact of combining assessment of venous congestion along with fluid responsiveness on acute kidney injury parameters in septic shock: 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 |
Jai Prakash Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology
All India Institute of Medical Sciences
Bhopal
Bhopal MADHYA PRADESH 462026 India |
| Phone |
8964891075 |
| Fax |
|
| Email |
jaiprakash.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Jai Prakash Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology
All India Institute of Medical Sciences
Bhopal
MADHYA PRADESH 462026 India |
| Phone |
8964891075 |
| Fax |
|
| Email |
jaiprakash.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Jai Prakash Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology
All India Institute of Medical Sciences
Bhopal
MADHYA PRADESH 462026 India |
| Phone |
8964891075 |
| Fax |
|
| Email |
jaiprakash.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India- 462020 |
|
|
Primary Sponsor
|
| Name |
Dr Jai Prakash Sharma Self |
| Address |
Department of Anaesthesiology
AIIMS, Bhopal
India 462020 |
| Type of Sponsor |
Research institution |
|
|
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 Gurudarshan S |
Department of Critical Care Medicine |
AIIMS, Bhopal Bhopal MADHYA PRADESH |
9480422047
gurudarshans614@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee (IHEC)- Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A498||Other bacterial infections of unspecified site, |
|
|
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 |
Adults admitted to the medical ICU with septic shock with or without Acute Kidney Injury
KDIGO Stage 1 or Stage 2 |
|
| ExclusionCriteria |
| Details |
Known case of significant valvular heart disease
• Acute Kidney Injury (KDIGO stage 3) or Acute Kidney Disease on admission
• End-stage renal disease on dialysis
• Child Pugh-C Cirrhosis
• Pregnancy
• Patients with life expectancy of less than 24 hours
• Inadequate echographic window precluding ultrasound assessment
• Patients with right heart failure due to any cause
• Pre-existing medical renal diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To assess the impact (diagnostic yield) of supplementing VExUS with fluid responsiveness assessment in patients with septic shock, with the aim of identifying impending fluid overload and preventing its adverse effect.
2) To investigate the evolving trends and trajectory patterns of renal function abnormalities |
Day1, day 3 and day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Signs of fluid overload- pleural effusion, B-lines on lung ultrasonography
Duration of mechanical ventilation
Length of ICU stay
Mortality at 28 days or during ICU stay, whichever is earlier |
Day 1
Day 3
Day 7 |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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="2" 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
|
This is a prospective, single-center observational study conducted in the Medical ICU at AIIMS Bhopal to evaluate whether combining venous congestion assessment using VExUS score with standard fluid responsiveness assessment can help identify impending fluid overload and prevent acute kidney injury in adults with septic shock. Approximately 100 patients aged 18 years or older with septic shock, with or without KDIGO stage 1–2 AKI, will be enrolled over 18 months. Patients with KDIGO stage 3 AKI, end-stage renal disease on dialysis, significant valvular heart disease, right-heart failure, inadequate ultrasound window, pregnancy, Child-Pugh C cirrhosis, or life expectancy less than 24 hours will be excluded. Each participant will undergo a single time-point assessment using tidal volume challenge and pulse pressure variation for fluid responsiveness, and ultrasound-based VExUS grading assessing IVC, hepatic, portal, and intrarenal Doppler. Patients will be categorized based on fluid responsiveness and congestion status; treatments received will follow routine ICU care. The primary outcome is development of AKI on day 7. Secondary outcomes include fluid overload, ICU length of stay, duration of mechanical ventilation, and 28-day mortality. Data will be collected from routine hospital records and confidentiality will be maintained.
|