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

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT02016053
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-14
• Study First Posted: 2013-12-19
• Status Verified: 2014-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis	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.

Secondary Outcome Measures

Name	Time	Method
To study predictive value of Cystatin C to determine progression or resolution of Acute Kidney Injury	1 Years
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.	1 Years

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India