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

NCT02016053 | Completed

• 1 other identifier: ILBS-AKI-02
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

500 patients with normal renal function. 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2014-11

Locations

IN (1)