NCT05151003

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

November 15, 2021

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Mortality in Acute Kidney Injury patients

    Collection of retrospective data from 2016

  • Creatinine clearance after discharge

    Collection of retrospective data from 2016

Study Arms (1)

Patients admitted to University Hospital San Martino, Genova, Italy

Adult patients admitted to University Hospital San Martino, Genova, Italy

Other: Data collection

Interventions

Collection and analysis of data related to AKI epidemiology, treatment and outcomes

Patients admitted to University Hospital San Martino, Genova, Italy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients admitted to University Hospital San Martino, Italy
  • We'll include also patients affected by Coronavirus disease 19 (COVID-19).

You may not qualify if:

  • Hemodialysis patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Martino

Genova, Italy

RECRUITING

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency, Chronic

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pasquale Esposito, Prof

    University of Genova, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nephrology

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 9, 2021

Study Start

August 1, 2021

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Patient data will be anonymized.

Locations