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CTRI Number  CTRI/2014/09/004971 [Registered on: 04/09/2014] Trial Registered Retrospectively
Last Modified On: 22/09/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   to diagnose the kidney injury in early stages by a biomarker 
Scientific Title of Study   Evaluation of Plasma and Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) as an early biomarker in predicting Acute Kidney Injury (AKI) in polu trauma patients in surgical Intensive Care Unit. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Babita Gupta 
Designation  Additional Professor, Anaesthesia 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 303,JPNATC, AIIMS, New Delhi
Room no 303,JPNATC, AIIMS, New Delhi
New Delhi
DELHI
110029
India 
Phone  09868397815  
Fax    
Email  drbabitagupta@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Babita Gupta 
Designation  Additional Professor, Anaesthesia 
Affiliation  AIIMS, New Delhi 
Address  Room no 303,JPNATC, AIIMS, New Delhi
Room no 303,JPNATC, AIIMS, New Delhi

DELHI
110029
India 
Phone  09868397815  
Fax    
Email  drbabitagupta@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Babita Gupta 
Designation  Additional Professor, Anaesthesia 
Affiliation  AIIMS, New Delhi 
Address  Room no 303,JPNATC, AIIMS, New Delhi
Room no 303,JPNATC, AIIMS, New Delhi

DELHI
110029
India 
Phone  09868397815  
Fax    
Email  drbabitagupta@hotmail.com  
 
Source of Monetary or Material Support  
ICMR, New Delhi 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  V. Ramalingawami Bhawan, Ansari Nagar, Post box Bo, 4911 New Delhi-110029 
Type of Sponsor  Government funding agency 
 
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 Babita Gupta  Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi  General ICU and Neuro ICU,Department of Anaesthesiology & Intensive Care,Jai Prakash Narayan Apex Trauma Center, Raj Nagar, New Delhi
New Delhi
DELHI 		 9868397815

drbabitagupta@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  1. Male or female arriving in ICU within 24 hours of trauma 2. 18 – 65 years of age ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NGAL ELISA Kit  Upon admission, and at 24 and 48 hours, 2 ml of blood will be collected in EDTA anti-coagulated vacuettes and 2 ml urine will be collected and centrifuged at 800 x g for 5 minutes and then frozen at -80oC. NGAL will be measured in these samples with an ELISA technique, using a commercially available kit (NGAL Rapid ELISA Kit Cat No. Kit 037 from Bioporta, Denmark) in the ELISA machine Biotek.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female arriving in ICU within 24 hours of trauma
2. 18 – 65 years of age
 
 
ExclusionCriteria 
Details  • Age < 18 years or >65 years
• Inability to obtain Informed Consent from patient or representative
• > 24 hrs after insult
• History of previous renal transplantation
• Chronic kidney disease - known medical history with admitting serum Cr >1.4 mg%
• Known or suspected ongoing pre-operative acute renal failure due to any cause, including pre-renal, intrinsic renal or post-renal (obstructive) etiologies (as evidenced by history, clinical presentation, USG, proteinuria (protein/creatinine ratio >0.5) in random urine sample and active urinary sediments , increasing serum creatinine or oliguria pre-operatively)
• Already receiving dialysis
• Any known or suspected renal ischemic insult(such as cardiac arrest) or nephrotoxic insult(other than intravascular contrast procedure) prior to admission
• Cardiac arrest before and during enrolment
• Transfer order within 24 hours
• Probability of survival > 24 hours less likely
• Transfer from other hospital
• Severe head injury with Glasgow Coma Scale of 3
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To establish the diagnostic ability of plasma NGAL and urine NGAL to diagnose AKI (as per RIFLE criteria) as computed by sensitivity and specificity in trauma patients in surgical ICU.
Time frame: 5 days after ICU admission
 		 2 years 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
• Cut off value of plasma and urine NGAL for various stages of AKI
• ICU stay
• Need for RRT
• Hospital Stay
• Mortality
 		 2 years 6 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   28/07/2014 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Neutrophil gelatinase-associated lipocalin (NGAL) is emerging as a novel biomarker of AKI from several etiologies. NGAL increases in both serum and urine 48 hours before the rise of creatinine and shows a strong correlation with change in creatinine concentration. An early diagnostic of AKI allows the early institutions of therapeutic measures fir the protection of renal function and improves the prognosis. This possibility is particularly important in the intensive care unit for the treatment of critically ill patients with potential nephrotoxic therapies. Use of NGAL as an early marker of AKI in Polytrauma patients in the surgical intensive care will be studied. This would enable early diagnostic and early protective strategy in patients identified with high risk for developing AKI.
 
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