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CTRI Number  CTRI/2022/10/046154 [Registered on: 04/10/2022] Trial Registered Prospectively
Last Modified On: 29/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   BNP Fluid Status And Acute Kidney Injury 
Scientific Title of Study   Evaluation of the predictive role of serial plasma BNP measurement in assessing fluid status and development of Acute Kidney Injury in Critically ill patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shameek Mukherjee 
Designation  DrNB Critical Care Medicine 1st year 
Affiliation  Grant Medical Foundation Ruby Hall Clinic 
Address  Grant Medical Foundation Ruby Hall Clinic NTU2 Main Building 2nd floor
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA
411001
India 
Phone  9748739567  
Fax  02066455628  
Email  mukherjeeshameek919@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kapil Zirpe 
Designation  HOD neuro and trauma unit 
Affiliation  Grant Medical Foundation Ruby Hall Clinic 
Address  Grant Medical Foundation Ruby Hall Clinic NTU2 Main Building 2nd floor
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA
411001
India 
Phone  9822844212  
Fax  02066455628  
Email  kapilzirpe@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kapil Zirpe 
Designation  HOD neuro and trauma unit 
Affiliation  Grant Medical Foundation Ruby Hall Clinic 
Address  Grant Medical Foundation Ruby Hall Clinic NTU2 Main Building 2nd floor
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA
411001
India 
Phone  9822844212  
Fax  02066455628  
Email  kapilzirpe@gmail.com  
 
Source of Monetary or Material Support  
Grant Medical Foundation Ruby Hall Clinic 
 
Primary Sponsor  
Name  Not Applicable 
Address  Not Applicable 
Type of Sponsor  Other [NIL] 
 
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 Shameek Mukherjee  Grant Medical Foundation Ruby Hall Clinic  Grant Medical Foundation Ruby Hall Clinic NTU2 main building 2nd floor 40 sassoon road Pune 411001 Maharashtra
Pune
MAHARASHTRA 		 9748739567
02066455628
mukherjeeshameek919@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Poona Medical Research Foundation Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patient admitted in the NTU with Age more than 18 years during the study period 
 
ExclusionCriteria 
Details  1 Age less than 18 years
2 Patients with chronic heart disease based on chart reviews
3 with an abnormal echocardiogram on admission systolic dysfunction
4 acute coronary syndromes
5 acute pulmonary embolisms
6 status post cardiopulmonary resuscitation
7 cor pulmonale
8 Chronic kidney disease on Hemodialysis
9 Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome will be evaluated in the form of development of AKI in critically ill patients  Within 72 hrs of admission into Critical Care Unit 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome will be evaluated in terms of mortality in the critically ill patients  Within 7days of admission into critical care unit 
 
Target Sample Size   Total Sample Size="111"
Sample Size from India="111" 
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)   10/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/10/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Brain natriuretic peptide (BNP) is a biomarker that can be easily obtained. It is a plasma neurohormone produced primarily by ventricular myocardiocytes in response to myocardial stretching and volume overload [25]. Recent studies have shown that BNP as a marker of fluid overload in incident haemodialysis patients [26]. On the other hand, few studies have correlated BNP levels with development of AKI and recovery from AKI in different set-ups [27-32]. 
Therefore, the hypothesis of this study is that the serial BNP level measurement could predict development of AKI and fluid status in critically ill patients and also it has the potential to be a convenient cost-effective marker to titrate fluid management to avoid overload and Acute kidney Injury in those patients.
 
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