Epidemiology of In-hospital Acute Kidney Injury (GENAKI)

November 27, 2023 updated by: Pasquale Esposito, Universita degli Studi di Genova

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Genova, Italy
        • Recruiting
        • IRCCS Policlinico San Martino
        • Contact:
        • Principal Investigator:
          • Pasquale Esposito
        • Sub-Investigator:
          • Francesca Viazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita degli Studi di Genova

Collaborators

Ospedale Policlinico San Martino

Investigators

  • Principal Investigator: Pasquale Esposito, Prof, University of Genova, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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