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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
Intervention / Comparator Agent
|
|
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 |