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NCT05151003 Clinical Trial

Epidemiology of In-hospital Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— GENAKI  

Official title:
Analysis of In-hospital Acute Kidney Injury Epidemiology, Treatment and Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05151003
Other study ID # CER Liguria: 515/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date December 1, 2025

Study information
Verified date November 2023
Source Universita degli Studi di Genova
Contact Pasquale Esposito
Phone 00390105555362
Email pasquale.esposito@unige.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective observational study to investigate acute kidney injury (AKI) epidemiology and outcomes in patients hospitalized in University Hospital San Martino, Genova, Italy.

Description:

A retrospective observational study was designed to investigate acute kidney injury (AKI) epidemiology and outcome in patients hospitalized in University Hospital San Martino, Genova, Italy. All data will be extracted from the hospital electronic database. The investigators will evaluate demographic, clinical and laboratory data, including age, sex, serum creatinine (sCr), sodium and electrolytes, intensive care unit (ICU) admission, length of hospital stay, death, comorbidities and primary diagnosis codes at the hospital discharge (using International Classification of Diseases-ICD-9- codes). The investigators will include also patients affected by Coronavirus disease 19 (COVID-19). The primary endpoint will be to describe AKI epidemiology, secondary endpoints will be to evaluate AKI-related risk factors and clinical outcomes, such as length of stay and mortality. Moreover, the investigators will describe the differences in the outcome and treatments of AKI patients in the medical wards and ICU.

Recruitment information / eligibility
Status Recruiting
Enrollment 60000
Est. completion date December 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients admitted to University Hospital San Martino, Italy - We'll include also patients affected by Coronavirus disease 19 (COVID-19). Exclusion Criteria: - Hemodialysis patients

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Data collection
Collection and analysis of data related to AKI epidemiology, treatment and outcomes

Locations
Country Name City State
Italy IRCCS Policlinico San Martino Genova

Sponsors (2)
Lead Sponsor Collaborator
Universita degli Studi di Genova Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute Kidney Injury incidence Rate of in-hospital Acute Kidney Injury incidence Collection of retrospective data from 2016
Primary Acute Kidney Injury severity Staging of in-hospital Acute Kidney Injury according to the KDIGO guidelines Collection of retrospective data from 2016
Secondary Mortality in Acute Kidney Injury patients Rate of in-hospital mortality among patients with Acute Kidney Injury Collection of retrospective data from 2016
Secondary Creatinine clearance after discharge Data on kidney function after the discharge in Acute Kidney Injury patients Collection of retrospective data from 2016
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