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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02016053

Enrollment

450

Registered

2013-12-19

Start date

2013-12-31

Completion date

2015-05-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

India

Outcome results