Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury

NCT ID: NCT02016053

Last Updated: 2015-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-05-31

Brief Summary

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500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Also biomarkers will be studied and validated as early predictors of AKI (Acute Kidney Injury).

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cirrhosis with baseline renal function

500 patients of cirrhosis with normal baseline renal function will be enrolled.

No interventions assigned to this group

Cirrhosis with Acute Kidney Injury (AKI).

Cirrhotics patients who present with AKI (Acute Kidney Injury) will be enrolled.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-AKI-02

Identifier Type: -

Identifier Source: org_study_id

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