- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02016053
Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Delhi
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New Delhi, Delhi, India, 110070
- Institute of Liver & Biliary Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled
Exclusion Criteria:
- Age < 18 or > 70 years
- Preexisting Chronic Renal Disease
- Patients with obstructive uropathy.
- Cirrhosis with HCC (HepatoCellular Carcinoma).
- Advanced cardiopulmonary disease
- Pregnancy
- Patients with extrahepatic malignancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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cirrhosis with baseline renal function
500 patients of cirrhosis with normal baseline renal function will be enrolled.
|
Cirrhosis with Acute Kidney Injury (AKI).
Cirrhotics patients who present with AKI (Acute Kidney Injury) will be enrolled.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis
Time Frame: 1 Year
|
Incidence is defined as No. of AKI (Acute Kidney Injury) patients during the follow up period of 1 year. Spectrum is defined as Grading of AKIN (Acute Kidney Injury Network) 1,2,3 in different child status (Child A,Child B and Child C) at the end . Natural History is defined as Occurrence of AKI (Acute Kidney Injury) and its recovery during the follow up period of 1 year. |
1 Year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To study predictive value of Cystatin C in comparison to serum creatinine as early predictor of development and outcome of AKI in a cohort of Cirrhotics.
Time Frame: 1 Years
|
1 Years
|
To study predictive value of Cystatin C to determine progression or resolution of Acute Kidney Injury
Time Frame: 1 Years
|
1 Years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-AKI-02
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