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CTRI Number  CTRI/2021/09/036171 [Registered on: 02/09/2021] Trial Registered Prospectively
Last Modified On: 01/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Role of NGAL in Acute Kidney injury with Liver cirrhosis 
Scientific Title of Study   Clinical profile and outcome of acute kidney injury in chronic liver disease: Role of novel biomarker NGAL in differential diagnosis of acute kidney injury 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  POOJA BM 
Designation  Research Scholar 
Affiliation  Kasturba Medical college 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College,Udupi

Udupi
KARNATAKA
576104
India 
Phone  9972650602  
Fax    
Email  poojadevadiga2527@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shiran Shetty 
Designation  Professor and Head 
Affiliation  Kasturba Medical College 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College,Udupi

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  shiran.shetty@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shiran Shetty 
Designation  Professor and Head 
Affiliation  Kasturba Medical College 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College,Udupi

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  shiran.shetty@manipal.edu  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Kasturba Medical College Manipal Academy of Higher Education Madav nagar Manipal  
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 Shiran shetty  Kasturba Medical College  4th floor, Department of Gastroenterology and Hepatology, Kasturba Medical college, Manipal Academy of Higher Education,Madhav nagar, Manipal
Udupi
KARNATAKA 
8861920517

shiran.shetty@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Clinically diagnosed with cirrhosis of
the liver with AKI as per
ICA criteria  
 
ExclusionCriteria 
Details  Kidney or liver transplant
Chronic hemodialysis before admission
or receiving nephrotoxic medications.
Chronic kidney disease
Renal insufficiency or urinary obstruction
Hepatocellular carcinoma or any other
advanced malignancy
UTI (Urinary tract infection)
(Positive urine culture or urine WBC > 10
per high power field)
Septic shock
Lack of informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the clinical profile, risk factors for AKI in Liver cirrhosis patients.
To study the impact of type and severity of AKI on mortality and hospital stay 
2 years  
 
Secondary Outcome  
Outcome  TimePoints 
To determine the ability of uNGAL to differentiate different types of AKI.
To determine the optimal cut-off value of uNGAL in different types of AKI using ROC
curve analysis.
To see the correlation of Urine NGAL with severity of AKI in Cirrhosis of liver
To study the association of urine NGAL level with 90-day mortality in Cirrhosis of liver. 
2 years 
 
Target Sample Size   Total Sample Size="188"
Sample Size from India="188" 
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)   06/09/2021 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Acute kidney injury (AKI) is a common complication occurring in cirrhotic patients. The morbidity and mortality rate of patients with cirrhosis of the liver with AKI is increasing at an alarming rate. Current practical biomarker serum creatinine has several limitations and cannot differentiate acute kidney injury AKI. Differentiation of AKI is vital for a good prognosis and helps in therapy. Several promising biomarkers have been identified during the last 10 years and among them, urine Neutrophil gelatinase-associated lipocalin (NGAL) appears to be a promising marker for diagnosis of AKI. Recent studies showed that NGAL excels as an early biomarker and helps in the differential diagnosis.

Based on this background knowledge, a study will be prospectively carried out for three years on Liver cirrhosis patients diagnosed with AKI visiting or admitted under the Nephrology and Department of Gastroenterology and hepatology. Patients recruited for the study will be diagnosed with AKI based on the ICA (The international club of ascites) criteria and evaluated to discover its etiology. The urine sample will be collected at the time of admission to evaluate the role of the most promising biomarkers Neutrophil gelatinase-associated lipocalin (NGAL) in the differential diagnosis of AKI and to see its association with the progression of AKI and the mortality

 
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