Epidemiology of In-hospital Acute Kidney Injury (GENAKI)

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Acute Kidney Injury; Dialysis; Complications
• Intervention / Treatment: Other: Data collection

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 60000

Contacts and Locations

• Study Contact: Name: Pasquale Esposito; Phone Number: 00390105555362; Email: pasquale.esposito@unige.it

Study Locations

• Italy
  • Genova, Italy
    • Recruiting
    • IRCCS Policlinico San Martino
    • Contact: Pasquale Esposito, Prof; Phone Number: 00390105557162; Email: pasquale.esposito@unige.it
    • Principal Investigator: Pasquale Esposito
    • Sub-Investigator: Francesca Viazzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to Policlinico Universitario San Martino, Genova, Italy (including those with COVID-19).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients admitted to University Hospital San Martino, Genova, Italy; Adult patients admitted to University Hospital San Martino, Genova, Italy	Other: Data collection; Collection and analysis of data related to AKI epidemiology, treatment and outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Kidney Injury incidence	Rate of in-hospital Acute Kidney Injury incidence	Collection of retrospective data from 2016
Acute Kidney Injury severity	Staging of in-hospital Acute Kidney Injury according to the KDIGO guidelines	Collection of retrospective data from 2016

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality in Acute Kidney Injury patients	Rate of in-hospital mortality among patients with Acute Kidney Injury	Collection of retrospective data from 2016
Creatinine clearance after discharge	Data on kidney function after the discharge in Acute Kidney Injury patients	Collection of retrospective data from 2016

Collaborators and Investigators

• Sponsor: Universita degli Studi di Genova
• Collaborators: Ospedale Policlinico San Martino
• Investigators: Principal Investigator: Pasquale Esposito, Prof, University of Genova, Italy

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: CER Liguria: 515/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data will be anonymized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No