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

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016053
• Other study ID #: ILBS-AKI-02
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: August 11, 2015
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: November 2014
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis	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	No
Secondary	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	No
Secondary	To study predictive value of Cystatin C to determine progression or resolution of Acute Kidney Injury		1 Years	No