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CTRI Number  CTRI/2021/09/036391 [Registered on: 09/09/2021] Trial Registered Prospectively
Last Modified On: 08/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Role of new parameter by renal doppler study to predict onset of acute kidney injury in patients who have developed sepsis.  
Scientific Title of Study   THE ROLE OF RENAL ARTERIO VENOUS COUPLING IN THE PREDICTION OF ACUTE RENAL INJURY IN PATIENTS WITH SEPSIS : A PROSPECTIVE OBSERVATIONAL STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangshaptak Saha 
Designation  Senior Resident Academic Critical care medicine. DM PDT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI  
Address  Department of Anaesthesiology, Pain Medicine & Critical Care Room No-5011, 5th floor Teaching Block, AIIMS, Ansari Nagar, New Delhi-110029

South
DELHI
110029
India 
Phone  09836139666  
Fax    
Email  goodced@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bikash Ranjan Ray 
Designation  Associate Professor, Department of Anaesthesiology, Pain Medicine and Critical Care  
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI  
Address  Department of Anaesthesiology, Pain Medicine & Critical Care Room No-5011, 5th floor Teaching Block, AIIMS, Ansari Nagar, New Delhi-110029

South
DELHI
110029
India 
Phone  9899323110  
Fax    
Email  bikashray.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sangshaptak Saha 
Designation  Senior Resident Academic Critical care medicine. DM PDT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI  
Address  Department of Anaesthesiology, Pain Medicine & Critical Care Room No-5011, 5th floor Teaching Block, AIIMS, Ansari Nagar, New Delhi-110029

South
DELHI
110029
India 
Phone  09836139666  
Fax    
Email  goodced@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences New Delhi  
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  AIIMS Ansari Nagar East Delhi 110029 
Type of Sponsor  Government medical college 
 
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 
Sangshaptak Saha  All India Institute Of Medical Sciences New Delhi   Department of Anaesthesiology, Pain Medicine & Critical Care Room No-5011, 5th floor Teaching Block, AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI 		 09836139666

goodced@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N178||Other acute kidney failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 All 18-65 years old patients admitted in AIIMS with sepsis during study duration who will give consent for the study
2 Feasibility of Renal doppler examinations within first 12 hours of admission.
3 Sepsis defined as by Sepsis 3 criteria
 
 
ExclusionCriteria 
Details  1 Poor abdominal echogenicity
2 Chronic kidney disease
3 AKI on admission
4 Unilateral nephrectomy
5 Renal transplant patients
6 Unilateral or bilateral hydronephrosis
7 Pregnant
8 Renal tumor
9 Suspected intra abdominal hypertension.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Primary objective
The goals of this study are to determine the relationship between the renal doppler parameters calculated during first 12 hours of ICU admission and MAKE-30 (Major Adverse Kidney Events within 30 days) in septic patients admitted to the general ICU.


 		 Primary objective
The goals of this study are to determine the relationship between the renal doppler parameters calculated during first 12 hours of ICU admission and MAKE-30 (Major Adverse Kidney Events within 30 days) in septic patients admitted to the general ICU.


 
 
Secondary Outcome  
Outcome  TimePoints 

Secondary objectives
To identify if these parameters can predict
Development of AKI-3
Increased requirement of renal replacement therapy
Increased ICU stay
Need for mechanical ventilation and
Increased mortality at 30days
 		 30 Days from onset, discharge or death  
 
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)   15/09/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [goodced@gmail.com].

  6. For how long will this data be available start date provided 09-07-2021 and end date provided 09-07-2021?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Sepsis is a leading cause of Acute kidney injury. Urine output and serum creatinine are not very accurate in predicting onset of AKI in sepsis. Available biomarkers have problems like availability, cost, sensitivity. Ultrasonography has come up as an excellent bedside technique in a variety of fields in ICU care. Renal resistive index has already shown to predict onset of AKI in post surgical patients. Trials on sepsis has not been done. We are wanting to see the role of renal arterio venous coupling, a new usg based marker, in the prediction of acute kidney injury in patients with sepsis.  
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