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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 


 
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