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CTRI Number  CTRI/2025/08/092882 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 11/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of giving fluids guided by renal ultrasound on the kidney failure in patients with severe infections 
Scientific Title of Study   Effect of Renal Doppler based Hemodynamic Support titration on the incidence of Acute Kidney Injury in patients with Septic Shock: A Single Blinded Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Singla 
Designation  AdditionalProfessor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Room no 016133 Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepak Singla 
Designation  AdditionalProfessor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Room no 016133 Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepak Singla 
Designation  AdditionalProfessor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Room no 016133 Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Rishikesh 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rishikesh 
Address  All India Institute of Medical Sciences, Veerbhadra road, Rishikesh. 249203 
Type of Sponsor  Research institution and hospital 
 
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 Deepak Singla  All India Institute of Medical Sciences  Room no 016133 Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra road, Rishikesh
Dehradun
UTTARANCHAL 
9068504999

deepak10.4u@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Renal doppler guided heamodynamic support  Renal doppler based parameters will be used to guide the fluids and vasopressors 
Comparator Agent  Standard therapy group  Standard parameters like inferior vena cava diameter, or pulse pressure variation will be used to guide the fluid and vasopressors 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients in septic shock 
 
ExclusionCriteria 
Details  Refusal to consent.
Patients with preexisting acute kidney injury.
Patients with preexisting renal diseases such as unilateral kidney. renal stone disease, renal failure, renal artery stenosis.
Patient having any preexisting cardiopulmonary illness
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Acute kidney injury  Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
PF Ratios   Day 1, 3 and 7 
Lactate  Day 1, 3 and 7 
Resolution of shock   Within 7 days 
Length of ICU stay
 
till 28 days 
Length of hospital stay
 
till 28 days 
Mortality  till 28 days 
 
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)   01/10/2025 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. Clinically, septic shock is identified by the need for vasopressor therapy to maintain a mean arterial pressure (MAP) of more than or equal to 65 mm Hg, along with a serum lactate level more than 2 mmol per L, despite adequate fluid resuscitation. Septic shock is a distributive shock which results from vasodilation and later damage to the microvascular endothelium resulting in capillary leakage and edema. So, exact titration of fluid becomes very important to maintain organ perfusion and to prevent the development of multi organ dysfunction syndrome (MODS). Organ systems affected in MODS include lungs resulting in acute respiratory distress syndrome (ARDS), kidney resulting in acute kidney injury (AKI), heart resulting in septic cardiomyopathy, brain resulting in septic encephalopathy and so on. Among these complications, AKI is one of the most common, affecting nearly 50 percent of patients in intensive care units. According to the KDIGO (Kidney Disease: Improving Global Outcomes) 2012 Clinical Practice Guidelines, acute kidney injury (AKI) is defined as any of the following: An increase in serum creatinine by more than or equal to 0.3 mg per dL within 48 hours, or an increase in serum creatinine to more than or equal to 1.5 times baseline, known or presumed to have occurred within the prior 7 days, or a urine output less than 0.5 mL per kg per h for 6 hours. 

Septic shock patients have developed AKI even with proper monitoring of parameters such as mean arterial pressure, central venous pressure, and lactate. The pathophysiology of AKI is due to variation in perfusion due to hemodynamic instability, excessive venous congestion, inflammation, and cytokine induced circulatory damage. These commonly used methods of monitoring fluid responsiveness have less sensitivity in predicting MODS, as none of these can quantify perfusion at organ level, further necessitating the need for newer indices. Hence the new techniques such as renal doppler have been evaluated to predict the risk of AKI in patients with sepsis. 

 
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